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

Last updated: September 30, 2024
Sponsor: Impax Laboratories, LLC
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Chronic Pain

Oral Facial Pain

Treatment

Zolmitriptan

Placebo

Clinical Study ID

NCT00617695
D1221C00005
  • Ages 12-17
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adolescents aged 12-17 years at the time of screening. Patients must not be enrolledif 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 theschool year

  • A history of usual migraine duration of >2-hours untreated for the 3 month prior toscreening

Exclusion

Exclusion Criteria:

  • A history of basilar, ophthalmoplegic or hemiplegic migraine headache or anypotentially serious neurological condition that is associated with headache orclinically significant abnormalities indicated from the medical history, physicalexam etc

  • Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine orcimetidine in the 2 weeks before randomization.

  • Evidence of ischemic heart disease, arrhythmia, accessory conduction pathwaydisorder as determined by central cardiologist using predetermined and agreed uponpediatric standards; Has uncontrolled hypertension

Study Design

Total Participants: 247
Treatment Group(s): 2
Primary Treatment: Zolmitriptan
Phase: 3
Study Start date:
September 01, 2003
Estimated Completion Date:
October 31, 2004