Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Zolmitriptan; Drug: Placebo

• Registration Number: NCT00617695
• Lead Sponsor: Impax Laboratories, LLC

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study Completion: 2004-10
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-18
• Status Verified: 2009-04
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

• Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled if they will turn 18 years of age within 12 weeks after randomization.
• An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines, considered to be moderately/severely disabling, per month on average during the school year
• A history of usual migraine duration of >2-hours untreated for the 3 month prior to screening

Exclusion Criteria

• A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache or clinically significant abnormalities indicated from the medical history, physical exam etc
• Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or cimetidine in the 2 weeks before randomization.
• Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder as determined by central cardiologist using predetermined and agreed upon pediatric standards; Has uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Zolmitriptan	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Headache response and pain-free response to treatment	15 minutes, 30 minutes, 45 minutes, 1.5 hours and 2 hours after randomized treatment

Secondary Outcome Measures

Name	Time	Method
Adverse Event reports	Four times within 12 weeks