Zomig - Treatment of Acute Migraine Headache in Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 10/19/2013 |
| Start Date: | September 2010 |
| End Date: | October 2013 |
| Contact: | Quintiles Worldwide |
| Email: | clinical.studies.ns@quintiles.com |
A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents
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).
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.
We found this trial at
29
sites
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