Overview

A Study of Prophylaxis for Migraine Patients With Topiramate in India

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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 the spread of disease).
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag Ltd.
Treatments:
Topiramate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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