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Completed

NCT Number: NCT00617695

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

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zolmitriptan

Drug

5mg nasal spray

Other names: Zomig

Placebo

Drug

Primary outcomes

  1. Headache response and pain-free response to treatment

    Time frame: 15 minutes, 30 minutes, 45 minutes, 1.5 hours and 2 hours after randomized treatment

Secondary outcomes

  1. Adverse Event reports

    Time frame: Four times within 12 weeks

Sponsors and collaborators

Lead sponsor

Impax Laboratories, LLC

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study With Single-blind, Placebo-challenge Evaluating the Efficacy of Zolmitriptan (Zomig) Nasal Spray 5mg, in the Treatment of Acute Migraine Headache in Adolescents.

Important dates

Study start
2003
Study completion
2004
First posted
Feb 18, 2008
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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