Status:
COMPLETED
Zomig - Treatment of Acute Migraine Headache in Adolescents
Lead Sponsor:
AstraZeneca
Conditions:
Migraine Headache
Eligibility:
All Genders
12-17 years
Phase:
PHASE4
Brief 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 Na...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
1653 Patients enrolled
Trial Details
Trial ID
NCT01211145
Start Date
September 1 2010
End Date
October 1 2013
Last Update
May 18 2016
Active Locations (74)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Fresno, California, United States
3
Research Site
Fullerton, California, United States
4
Research Site
Newport Beach, California, United States