A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches
Long-Term, Open-Label Safety Study of Oral Almotriptan Malate 12.5 mg in the Treatment of Migraine in Adolescents
2 other identifiers
interventional
447
1 country
49
Brief Summary
The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2005
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
December 6, 2013
CompletedFebruary 21, 2014
January 1, 2014
2 years
November 18, 2005
October 11, 2013
January 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Pain Free Headaches at 2 and 24 Hours Post-Dose
Headache pain free is defined as a decrease in baseline pain intensity from severe, moderate or mild to no pain, without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 2 (or 24) hours of first dose of study medication. Sustained pain free is defined as pain free at 2 and 24 hours without the use of supplemental pain medication and/or anti-emetic medication (including a second dose of study medication) within 24 hours.
2 hours and 24 hours post-dose
Secondary Outcomes (5)
Number of Headaches Achieving Pain Relief at 2 and 24 Hours Post-Dose
2 hours and 24 hours post-dose
Number of Headaches With Photophobia
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Phonophobia
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Nausea
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Number of Headaches With Vomiting
Baseline (after onset of migraine headache pain and before treatment), 2 hours and 24 hours post-dose
Study Arms (1)
Almotriptan Malate
EXPERIMENTALPatients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Interventions
Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain
Eligibility Criteria
You may qualify if:
- Have a history of migraine for at least one year
- Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
- Able to swallow oral medication
- Able to complete a headache diary
- Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)
You may not qualify if:
- Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
- Have 15 or more days within a month in which you have a headache
- Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
- Experience more than 6 non-migraine headaches per month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen-Ortho LLClead
- Ortho-McNeil Neurologics, Inc.collaborator
Study Sites (49)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Montgomery, Alabama, United States
Unknown Facility
Oxford, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Jonesboro, Arkansas, United States
Unknown Facility
Little Rock, Arkansas, United States
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Santa Monica, California, United States
Unknown Facility
Centennial, Colorado, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Loxahatchee Groves, Florida, United States
Unknown Facility
Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Snellville, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Topeka, Kansas, United States
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Witchita, Kansas, United States
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Louisville, Kentucky, United States
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Ann Arbor, Michigan, 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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Endwell, New York, United States
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Mineola, New York, United States
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Mount Vernon, New York, United States
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Plainview, New York, United States
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Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Alcoa, Tennessee, United States
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Bristol, Tennessee, United States
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Germantown, Tennessee, United States
Unknown Facility
Morristown, Tennessee, United States
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Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
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Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
San Marcos, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Madison, Wisconsin, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Medical Affairs
- Organization
- Janssen-Ortho LLC
Study Officials
- STUDY DIRECTOR
Janssen Ortho LLC Clinical Trial
Janssen-Ortho LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
December 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 21, 2014
Results First Posted
December 6, 2013
Record last verified: 2014-01