Zomig - Treatment of Acute Migraine Headache in Adolescents

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Oxazolidinones; Zolmitriptan

Criteria

Inclusion Criteria:

• Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.

• Established diagnosis of migraine.

• History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion Criteria:

• Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.

• A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.

• Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.