Zomig - Treatment of Acute Migraine Headache in Adolescents
NCT ID: NCT01211145
Last Updated: 2016-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1653 participants
INTERVENTIONAL
2010-09-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Placebo
Placebo
Placebo nasal spray
2
ZOMIG 0.5 mg
Zolmitriptan
0.5 mg nasal spray
3
ZOMIG 2.5 mg
Zolmitriptan
2.5 mg nasal spray
4
ZOMIG 5.0 mg
Zolmitriptan
5.0 mg nasal spray
Interventions
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Placebo
Placebo nasal spray
Zolmitriptan
0.5 mg nasal spray
Zolmitriptan
2.5 mg nasal spray
Zolmitriptan
5.0 mg nasal spray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of migraine.
* History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.
Exclusion Criteria
* 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.
12 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Rohini Chitra
Role: STUDY_DIRECTOR
AZ Pharmaceuticals, US
Paul Winner
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of The King's Daughters
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Fresno, California, United States
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Fullerton, California, United States
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Newport Beach, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Thornton, Colorado, United States
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Fairfield, Connecticut, United States
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Boca Raton, Florida, United States
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Hallandale, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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North Palm Beach, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Owensboro, Kentucky, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Plymouth, Minnesota, United States
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Ocean Springs, Mississippi, United States
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Olive Branch, Mississippi, United States
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Columbia, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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The Bronx, New York, United States
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Cary, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Indiana, Pennsylvania, United States
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Jackson, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
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Salt Lake City, Utah, United States
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South Jordan, Utah, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Middleton, Wisconsin, United States
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Mikkeli, , Finland
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Turku, , Finland
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Miskolc, , Hungary
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Nagykanizsa, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Sopron, , Hungary
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Szekszárd, , Hungary
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Riga, , Latvia
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Valmiera, , Latvia
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Elblag, , Poland
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Gdansk, , Poland
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Kielce, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Belgrade, , Serbia
Research Site
Novi Sad, , Serbia
Research Site
Dolný Kubín, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Zvolen, , Slovakia
Countries
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Related Links
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D1220C00001 Clinical Study Report Synopsis
Other Identifiers
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D1220C00001
Identifier Type: -
Identifier Source: org_study_id
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