Status:
COMPLETED
A Study of Prophylaxis for Migraine Patients With Topiramate in India
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of topiramate in preventing migraine among Indian participants requiring prophylaxis (measure taken to maintain health and prevent...
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites) study. In this study approximately 209 participants will be observed. Partici...
Eligibility Criteria
Inclusion
- Participants who experiencing migraine three or more times per month and require prophylaxis medication
- Participants having at least 6 months of migraine history (diagnosed as per international headache society criteria with or without aura)
- Other indications for migraine prophylaxis are: the use of acute treatment medication too frequently (more than 2 treatment days per week); an increasing frequency of headaches that are non-responsive to acute therapy; requiring rescue therapy more than once a month
- Participants who are seen to benefit from topiramate based upon the physician's judgment
Exclusion
- Headaches other than migraine or episodic tension or sinus headaches or having headaches exceeding 15 days per month
- Onset of migraine after age 50
- An exclusively migraine aura without headache or a painful condition other than migraine pain
- Having significant history of unstable medical disease
- At risk in terms of the contraindication in the product insert of topiramate
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT01836874
Start Date
May 1 2007
End Date
July 1 2008
Last Update
April 22 2013
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