Migraine Headache Clinical Trial
— TEENZOfficial title:
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
| Verified date | January 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 1653 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 17 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Estonia | Research Site | Tallinn | |
| Estonia | Research Site | Tartu | |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Mikkeli | |
| Finland | Research Site | Turku | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Debrecen | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Miskolc | |
| Hungary | Research Site | Nagykanizsa | |
| Hungary | Research Site | Nyiregyhaza | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Sopron | |
| Hungary | Research Site | Szekszárd | |
| Latvia | Research Site | Riga | |
| Latvia | Research Site | Valmiera | |
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Elblag | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Kielce | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Poznan | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Novi Sad | |
| Slovakia | Research Site | Dolny Kubin | |
| Slovakia | Research Site | Nitra | |
| Slovakia | Research Site | Zvolen | |
| United States | Research Site | Akron | Ohio |
| United States | Research Site | Ann Arbor | Michigan |
| United States | Research Site | Boca Raton | Florida |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Cary | North Carolina |
| United States | Research Site | Centennial | Colorado |
| United States | Research Site | Charlottesville | Virginia |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Columbia | Missouri |
| United States | Research Site | Fairfield | Connecticut |
| United States | Research Site | Fresno | California |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Hallandale Beach | Florida |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | Indiana | Pennsylvania |
| United States | Research Site | Jackson | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami Lakes | Florida |
| United States | Research Site | Middleton | Wisconsin |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Newport Beach | California |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | North Palm Beach | Florida |
| United States | Research Site | Ocean Springs | Mississippi |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Olive Branch | Mississippi |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Owensboro | Kentucky |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Plymouth | Minnesota |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Francisco | California |
| United States | Research Site | South Jordan | Utah |
| United States | Research Site | Spring | Texas |
| United States | Research Site | Springfield | Missouri |
| United States | Research Site | St Louis | Missouri |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Thornton | Colorado |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Estonia, Finland, Hungary, Latvia, Poland, Serbia, Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain-free Status at 2 Hours Post-treatment | 2 hours post-treatment. | No | |
| Secondary | Pain-free Status at 24 Hours Post-treatment | 24 hours post-treatment | No | |
| Secondary | Headache Response at 2 Hours Post-treatment | Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment. | 2 hours post-treatment | No |
| Secondary | Headache Response at 24 Hours Post-treatment | Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment. | 24 hours post-treatment | No |
| Secondary | Sustained Headache Response at 2 Hours | Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment. | Up to 2 hours post-treatment | No |
| Secondary | Use of Rescue Medication During the First 24 Hours After Treatment | 24 hours post-treatment. | No |
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