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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.

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Official Title

The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Zomig - Treatment of Acute Migraine Headache in Adolescents

NCT ID

Therapeutic Area

D1220C00001 Clinical Study Report Synopsis

Research Site

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

Age Continuous

Gender, Male/Female

Full analysis set (last observation carried forward)

Pain-free status at 2 hours post-treatment

Pain-free status at 24 hours post-treatment

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.

Headache response at 2 hours post-treatment

Headache response at 24 hours post-treatment

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.

Sustained headache response at 2 hours

Use of rescue medication during the first 24 hours after treatment

Overall Study

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.

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

Zomig - Treatment of Acute Migraine Headache in Adolescents - TEENZ

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D1220C00001 Clinical Study Report Synopsis

D1220C00001 Revised CSP 3 Redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator