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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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1

Group Type EXPERIMENTAL

Zolmitriptan

Intervention Type DRUG

5mg nasal spray

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Zolmitriptan

5mg nasal spray

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Zomig

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No