Zomig - Treatment of Acute Migraine Headache in Adolescents - TEENZ

Study identifier:D1220C00001

ClinicalTrials.gov identifier:NCT01211145

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents

Medical condition

Migraine Headache

Phase

Phase 4

Healthy volunteers

Study drug

Placebo, Zolmitriptan

Sex

All

Actual Enrollment

1653

Study type

Interventional

Age

12 Years - 17 Years

Date

Study Start Date: 01 Sept 2010

Primary Completion Date: 01 Oct 2013

Study Completion Date: 01 Oct 2013

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Tallinn, Estonia

Location

Research Site

Tartu, Estonia

Location

Research Site

Helsinki, Finland

Location

Research Site

Mikkeli, Finland

Location

Research Site

Turku, Finland

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Gyula, Hungary

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Placebo nasal spray
Experimental: 2 ZOMIG 0.5 mg	Drug: Zolmitriptan 0.5 mg nasal spray Other Name: Zomig® Nasal Spray
Experimental: 3 ZOMIG 2.5 mg	Drug: Zolmitriptan 2.5 mg nasal spray Other Name: Zomig® Nasal Spray
Experimental: 4 ZOMIG 5.0 mg	Drug: Zolmitriptan 5.0 mg nasal spray Other Name: Zomig® Nasal Spray

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter study was conducted between 7 October 2010 and 31 October 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had a 30 day run-in period and up to a 10-week double-blind treatment period. Patients were randomized to receive ZOMIG nasal spray 0.5, 2.5, 5.0 mg, or matching placebo spray to treat a migraine headache. 1653 patients were enrolled, 798 were randomized.

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Participant Flow: Overall Study

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
STARTED	296	115	99	288
COMPLETED	270^[1]	98	86	268
NOT COMPLETED	26	17	13	20
Reason not specified	3	2	2	1
Lost to Follow-up	3	2	1	2
Study-specific withdrawal criteria	1	0	0	0
Severe noncompliance to protocol	1	0	0	0
Eligibility criteria not fulfilled	16	12	10	15
Patient decision	2	1	0	2

[1]	1 patient was not counted as completed or discontinued due to incomplete information (N=270-1=269).

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Baseline Measures

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg	Total
Number of Participants [units: Participants]	296	115	99	288	798
Age Continuous ^[1] [units: Years] Mean ± Standard Deviation	14.3 ± 1.67	14.5 ± 1.72	14.6 ± 1.77	14.5 ± 1.67	14.4 ± 1.69
Gender, Male/Female ^[2] [units: Participants]
Female	188	71	62	172	493
Male	108	44	37	116	305

Outcome Measures

1. Primary Outcome Measure: Pain-free status at 2 hours post-treatment [ Time Frame: 2 hours post-treatment. ]

Measure Type	Primary
Measure Name	Pain-free status at 2 hours post-treatment
Measure Description
Time Frame	2 hours post-treatment.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (last observation carried forward)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Measured Values

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Number of Participants Analyzed [units:participants]	253	91	81	229
Pain-free status at 2 hours post-treatment [units: Participants]
Yes	42	20	20	68
No	211	71	61	161

Statistical Analysis 1 for Pain-free status at 2 hours post-treatment

Groups^[1]	Placebo, ZOMIG 0.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.312
Odds Ratio (OR)^[5]	1.37
95% Confidence Interval	( 0.75 to 2.50 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 0.5 mg/Placebo

Statistical Analysis 2 for Pain-free status at 2 hours post-treatment

Groups^[1]	Placebo, ZOMIG 2.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.071
Odds Ratio (OR)^[5]	1.76
95% Confidence Interval	( 0.95 to 3.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 2.5 mg/Placebo

Statistical Analysis 3 for Pain-free status at 2 hours post-treatment

Groups^[1]	Placebo, ZOMIG 5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	<.001
Odds Ratio (OR)^[5]	2.18
95% Confidence Interval	( 1.40 to 3.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 5.0 mg/Placebo

2. Secondary Outcome Measure: Pain-free status at 24 hours post-treatment [ Time Frame: 24 hours post-treatment ]

Measure Type	Secondary
Measure Name	Pain-free status at 24 hours post-treatment
Measure Description
Time Frame	24 hours post-treatment
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (observed case)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Measured Values

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Number of Participants Analyzed [units:participants]	251	91	80	227
Pain-free status at 24 hours post-treatment [units: Participants]
Yes	155	59	60	155
No	96	32	20	72

Statistical Analysis 1 for Pain-free status at 24 hours post-treatment

Groups^[1]	Placebo, ZOMIG 0.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.575
Odds Ratio (OR)^[5]	1.15
95% Confidence Interval	( 0.70 to 1.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 0.5 mg/Placebo

Statistical Analysis 2 for Pain-free status at 24 hours post-treatment

Groups^[1]	Placebo, ZOMIG 2.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.032
Odds Ratio (OR)^[5]	1.87
95% Confidence Interval	( 1.06 to 3.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 2.5 mg/Placebo

Statistical Analysis 3 for Pain-free status at 24 hours post-treatment

Groups^[1]	Placebo, ZOMIG 5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.137
Odds Ratio (OR)^[5]	1.33
95% Confidence Interval	( 0.91 to 1.95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 5.0 mg/Placebo

3. Secondary Outcome Measure: Headache response at 2 hours post-treatment [ Time Frame: 2 hours post-treatment ]

Measure Type	Secondary
Measure Name	Headache response at 2 hours post-treatment
Measure Description	Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
Time Frame	2 hours post-treatment
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (last observation carried forward)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Measured Values

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Number of Participants Analyzed [units:participants]	253	91	81	229
Headache response at 2 hours post-treatment [units: Participants]
Yes	99	40	43	116
No	154	51	38	113

Statistical Analysis 1 for Headache response at 2 hours post-treatment

Groups^[1]	Placebo, ZOMIG 0.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.458
Odds Ratio (OR)^[5]	1.20
95% Confidence Interval	( 0.74 to 1.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 0.5 mg/Placebo

Statistical Analysis 2 for Headache response at 2 hours post-treatment

Groups^[1]	Placebo, ZOMIG 2.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.021
Odds Ratio (OR)^[5]	1.82
95% Confidence Interval	( 1.09 to 3.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 2.5 mg/Placebo

Statistical Analysis 3 for Headache response at 2 hours post-treatment

Groups^[1]	Placebo, ZOMIG 5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.010
Odds Ratio (OR)^[5]	1.61
95% Confidence Interval	( 1.12 to 2.32 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 5.0 mg/Placebo

4. Secondary Outcome Measure: Headache response at 24 hours post-treatment [ Time Frame: 24 hours post-treatment ]

Measure Type	Secondary
Measure Name	Headache response at 24 hours post-treatment
Measure Description	Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
Time Frame	24 hours post-treatment
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (observed case)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Measured Values

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Number of Participants Analyzed [units:participants]	251	91	80	227
Headache response at 24 hours post-treatment [units: Participants]
Yes	170	63	61	168
No	81	28	19	59

Statistical Analysis 1 for Headache response at 24 hours post-treatment

Groups^[1]	Placebo, ZOMIG 0.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.753
Odds Ratio (OR)^[5]	1.09
95% Confidence Interval	( 0.64 to 1.84 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 0.5 mg/Placebo

Statistical Analysis 2 for Headache response at 24 hours post-treatment

Groups^[1]	Placebo, ZOMIG 2.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.145
Odds Ratio (OR)^[5]	1.55
95% Confidence Interval	( 0.86 to 2.79 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 2.5 mg/Placebo

Statistical Analysis 3 for Headache response at 24 hours post-treatment

Groups^[1]	Placebo, ZOMIG 5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.127
Odds Ratio (OR)^[5]	1.37
95% Confidence Interval	( 0.91 to 2.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 5.0 mg/Placebo

5. Secondary Outcome Measure: Sustained headache response at 2 hours [ Time Frame: Up to 2 hours post-treatment ]

Measure Type	Secondary
Measure Name	Sustained headache response at 2 hours
Measure Description	Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.
Time Frame	Up to 2 hours post-treatment
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (observed case)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Measured Values

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Number of Participants Analyzed [units:participants]	251	91	81	224
Sustained headache response at 2 hours [units: Participants]
Yes	59	27	27	66
No	192	64	54	158

Statistical Analysis 1 for Sustained headache response at 2 hours

Groups^[1]	Placebo, ZOMIG 0.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.274
Odds Ratio (OR)^[5]	1.35
95% Confidence Interval	( 0.79 to 2.32 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 0.5 mg/Placebo

Statistical Analysis 2 for Sustained headache response at 2 hours

Groups^[1]	Placebo, ZOMIG 2.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.067
Odds Ratio, log^[5]	1.67
95% Confidence Interval	( 0.96 to 2.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 2.5 mg/Placebo

Statistical Analysis 3 for Sustained headache response at 2 hours

Groups^[1]	Placebo, ZOMIG 5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.127
Odds Ratio (OR)^[5]	1.38
95% Confidence Interval	( 0.91 to 2.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 5.0 mg/Placebo

6. Secondary Outcome Measure: Use of rescue medication during the first 24 hours after treatment [ Time Frame: 24 hours post-treatment. ]

Measure Type	Secondary
Measure Name	Use of rescue medication during the first 24 hours after treatment
Measure Description
Time Frame	24 hours post-treatment.
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (observed cases)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Measured Values

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Number of Participants Analyzed [units:participants]	253	91	81	231
Use of rescue medication during the first 24 hours after treatment [units: Participants]
Yes	80	22	18	47
No	173	69	63	184

Statistical Analysis 1 for Use of rescue medication during the first 24 hours after treatment

Groups^[1]	Placebo, ZOMIG 0.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.153
Odds Ratio (OR)^[5]	0.67
95% Confidence Interval	( 0.38 to 1.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 0.5 mg/Placebo

Statistical Analysis 2 for Use of rescue medication during the first 24 hours after treatment

Groups^[1]	Placebo, ZOMIG 2.5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.087
Odds Ratio (OR)^[5]	0.59
95% Confidence Interval	( 0.33 to 1.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 2.5 mg/Placebo

Statistical Analysis 3 for Use of rescue medication during the first 24 hours after treatment

Groups^[1]	Placebo, ZOMIG 5 mg
Non-Inferiority/Equivalence Test^[2]	No
Method^[3]	Regression, Logistic
P-Value^[4]	.004
Odds Ratio (OR)^[5]	0.54
95% Confidence Interval	( 0.36 to 0.83 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Additional details about a non-inferiority or equivalence analysis:
	No text entered.
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Unadjusted
[5]	Other relevant estimation information:
	ZOMIG 5.0 mg/Placebo

Serious Adverse Events

Time Frame	No text entered.
Additional Description	Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Serious Adverse Events

	Placebo	ZOMIG 0.5 mg	ZOMIG 2.5 mg	ZOMIG 5 mg
Total, serious adverse events
# participants affected / at risk	0/253 (0.00%)	0/92 (0.00%)	0/81 (0.00%)	0/231 (0.00%)

Other Adverse Events

Time Frame	No text entered.
Additional Description	Safety Analysis Set (Number of Patients at Risk: Placebo=253; ZOMIG 0.5 mg=92; ZOMIG 2.5 mg=81; ZOMIG 5 mg=231)

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
Placebo	Placebo to ZOMIG nasal spray
ZOMIG 0.5 mg	ZOMIG nasal spray
ZOMIG 2.5 mg	ZOMIG nasal spray
ZOMIG 5 mg	ZOMIG nasal spray

Other Adverse Events

Placebo

ZOMIG 0.5 mg

ZOMIG 2.5 mg

ZOMIG 5 mg

Total, other (not including serious) adverse events

# participants affected / at risk

25/253 (9.88%)

14/92 (15.22%)

9/81 (11.11%)

59/231 (25.54%)

Nervous system disorders

Dysgeusia¹,^†

# participants affected / at risk

3/253 (1.19%)

6/92 (6.52%)

5/81 (6.17%)

29/231 (12.55%)

# events

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

2/253 (0.79%)

1/92 (1.09%)

0/81 (0.00%)

6/231 (2.60%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal discomfort¹,^†

# participants affected / at risk

4/253 (1.58%)

1/92 (1.09%)

2/81 (2.47%)

7/231 (3.03%)

# events

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹,^†

# participants affected / at risk

4/253 (1.58%)

1/92 (1.09%)

0/81 (0.00%)

7/231 (3.03%)

# events

Gastrointestinal disorders

Nausea¹,^†

# participants affected / at risk

3/253 (1.19%)

0/92 (0.00%)

1/81 (1.23%)

5/231 (2.16%)

# events

Gastrointestinal disorders

Abdominal pain upper^†

# participants affected / at risk

3/253 (1.19%)

0/92 (0.00%)

1/81 (1.23%)

1/231 (0.43%)

# events

Nervous system disorders

Paraesthesia^†

# participants affected / at risk

1/253 (0.40%)

1/92 (1.09%)

1/81 (1.23%)

2/231 (0.87%)

# events

Nervous system disorders

Hypoaesthesia^†

# participants affected / at risk

1/253 (0.40%)

1/92 (1.09%)

0/81 (0.00%)

1/231 (0.43%)

# events

Nervous system disorders

Somnolence^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

3/231 (1.30%)

# events

Nervous system disorders

Bradykinesia^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Nervous system disorders

Burning sensation^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Nervous system disorders

Head discomfort^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Gastrointestinal disorders

Vomiting^†

# participants affected / at risk

3/253 (1.19%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

Gastrointestinal disorders

Oral discomfort^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Gastrointestinal disorders

Oral pain^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Gastrointestinal disorders

Oral pruritus^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Throat irritation^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

3/231 (1.30%)

# events

Respiratory, thoracic and mediastinal disorders

Pharyngeal oedema^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

2/231 (0.87%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinalgia^†

# participants affected / at risk

2 /253 (0.79%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Sneezing^†

# participants affected / at risk

2/253 (0.79%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Hiccups^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Throat tightness^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Respiratory, thoracic and mediastinal disorders

Upper-airway cough syndrome^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

General disorders

Fatigue^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

3/231 (1.30%)

# events

General disorders

Asthenia^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

General disorders

Chills^†

# participants affected / at risk

0/253 (0.00%)

1/92 (1.09%)

0/81 (0.00%)

1/231 (0.43%)

# events

General disorders

Facial pain^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

General disorders

Feeling cold^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

General disorders

Feeling hot^†

# participants affected / at risk

0/253 (0.00%)

1/92 (1.09%)

0/81 (0.00%)

0/231 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Arthralgia^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

2/231 (0.87%)

# events

Musculoskeletal and connective tissue disorders

Joint stiffness^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Muscular weakness^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal discomfort^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Musculoskeletal stiffness^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Myalgia^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Neck pain^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Musculoskeletal and connective tissue disorders

Pain in jaw^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Eye disorders

Eye irritation^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Eye disorders

Photopsia^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Eye disorders

Vision blurred^†

# participants affected / at risk

1/253 (0.40%)

0/92 (0.00%)

0/81 (0.00%)

0/231 (0.00%)

# events

Ear and labyrinth disorders

Vertigo^†

# participants affected / at risk

1/253 (0.40%)

1/92 (1.09%)

0/81 (0.00%)

0/231 (0.00%)

# events

Infections and infestations

Influenza^†

# participants affected / at risk

0/253 (0.00%)

1/92 (1.09%)

0/81 (0.00%)

0/231 (0.00%)

# events

Injury, poisoning and procedural complications

Administration related reaction^†

# participants affected / at risk

0/253 (0.00%)

1/92 (1.09%)

0/81 (0.00%)

0/231 (0.00%)

# events

Psychiatric disorders

Disorientation^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

Skin and subcutaneous tissue disorders

Erythema^†

# participants affected / at risk

0/253 (0.00%)

0/92 (0.00%)

0/81 (0.00%)

1/231 (0.43%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 16.1
2	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	Jamie Mullen, Medical Science Director
Organization:	AstraZeneca
Phone	781-472-5032
E-mail:	[email protected]

Documents available

D1220C00001 Clinical Study Report Synopsis
Download
D1220C00001 Revised CSP 3 Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Rohini Chitra

AZ Pharmaceuticals, US

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

D1220C00001 Clinical Study Report Synopsis

D1220C00001 Revised CSP 3 Redacted

Trial Results Summaries