Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.
TOPAMAX (Topiramate) Intervention to Prevent Transformation of Episodic Migraine: The Topiramate INTREPID Study
1 other identifier
interventional
385
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether Topiramate is effective in preventing the development of chronic daily headache among patients with episodic migraine headaches.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2005
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
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMay 19, 2011
March 1, 2010
September 13, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy parameter will be whether or not a patient experiences 15 or more headache days (migraine and non-migraine) during the last 28 days of the study.
Secondary Outcomes (1)
Time to development of transformed migraine;occurrence of transformation as function of baseline headache days;change in the average rate of migraine days;percentage change in the average rate of migraine days;50%,75%, and 100% reduction in migraine days
Interventions
Eligibility Criteria
You may qualify if:
- To qualify for this study you must be 18-65 years old
- have a history of migraine headaches for at least 1 year
- experience at least 10 but less than 15 migraine headache days and less than 15 total headache days/month
- able to take oral medication
- able to understand and sign the informed consent and to complete headache diaries.
You may not qualify if:
- You will not be able to participate in the study if you previously discontinued Topiramate because it did not make you feel better or it made you feel different
- have migraine aura without headache
- have a positive urine drug screen
- have a history of kidney stones
- have a history of suicide attempt
- pregnant females
- already on a migraine preventive medicine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lipton RB, Silberstein S, Dodick D, Cady R, Freitag F, Mathew N, Biondi DM, Ascher S, Olson WH, Hulihan J. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011 Jan;31(1):18-30. doi: 10.1177/0333102410372427. Epub 2010 May 17.
PMID: 20974598DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho McNeil Neurologics, Inc. Clinical Trial
Ortho-McNeil Neurologics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
September 1, 2005
Study Completion
August 1, 2007
Last Updated
May 19, 2011
Record last verified: 2010-03