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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00617695

Enrollment

247

Registered

2008-02-18

Start date

2003-09-30

Completion date

2004-10-31

Last updated

2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain

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

Interventions

DRUGZolmitriptan

5mg nasal spray

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse Event reports	Four times within 12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026