A Study of Prophylaxis for Migraine Patients With Topiramate in India

Completed

• Conditions: Migraine
• Interventions: Drug: No intervention

• Registration Number: NCT01836874
• Lead Sponsor: Janssen-Cilag Ltd.

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 the spread of disease).

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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2013-03-21
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-17
• Last Update Submitted: 2013-04-17
• Study First Posted: 2013-04-22
• Last Update Posted: 2013-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Topiramate	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 3 months
Number of adverse events	Up to 3 months
Number of participants with incidence of discontinuation of study medication	Up to 3 months
Reason for participant's discontinuation of study medication	Up to 3 months
Change from baseline in the body weight	Baseline (screening) to 3 months
Physician's overall assessment of topiramate at the end of the treatment period	Month 3	Physician's overall assessment is assessed at the end of study on a 5-point scale wherein 1= Very Good, 2 = Good, 3 = No Change, 4 = Poor \& 5 = Very Poor. Higher scores indicate worsening.
Participant's overall assessment of topiramate at the end of the treatment period	Month 3	Participant's overall assessment is assessed at the end of study on a 5-point scale wherein 1= Very Good, 2 = Good, 3 = No Change, 4 = Poor \& 5 = Very Poor. Higher scores indicate worsening.