A Study of Prophylaxis for Migraine Patients With Topiramate in India
Information source: Janssen-Cilag Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: No intervention (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen-Cilag Ltd. Official(s) and/or principal investigator(s): Janssen-Cilag Ltd. Clinical Trial, Study Director, Affiliation: Janssen-Cilag Ltd.
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).
Clinical Details
Official title: Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of participants with adverse eventsNumber of adverse events Number of participants with incidence of discontinuation of study medication Reason for participant's discontinuation of study medication Change from baseline in the body weight Participant's overall assessment of topiramate at the end of the treatment period Physician's overall assessment of topiramate at the end of the treatment period
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. Participants receiving topiramate will be observed monthly for 3 months. Safety
assessments will include evaluation of adverse events and body weight of the participants
which will be monitored throughout the study. The total duration of this study will be
approximately 3 months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 2007
Last updated: April 17, 2013
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