Zomig - Treatment of Acute Migraine Headache in Adolescents

Completed · Phase 4 · Has a placebo group

Conditions studied: Migraine Headache

In brief

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).

Key facts

Study ID

NCT01211145

Run by

AstraZeneca

People needed

1653

Starts

2010-09-01

Expected to finish

2013-10-01

Last updated by the study team

2016-05-18

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Fresno, California, United States
• Research Site — Fullerton, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Centennial, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Thornton, Colorado, United States
• Research Site — Fairfield, Connecticut, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Hallandale, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami Lakes, Florida, United States
• Research Site — North Palm Beach, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Owensboro, Kentucky, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Plymouth, Minnesota, United States
• Research Site — Ocean Springs, Mississippi, United States
• Research Site — Olive Branch, Mississippi, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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