A Study of Prophylaxis for Migraine Patients With Topiramate in India

Study Overview
=================
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.

Official Title
-----------------
Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: No intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Topiramate<br> | Drug: No intervention<br>* This is an observational study. Participants receiving topiramate 25 mg once-a-day for 1 week and later on, receiving increase dose up to 200 mg, twice-a-day, orally will be observed for 3 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Participant's overall assessment of topiramate at the end of the treatment period | 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. | Month 3 | 
| Physician's overall assessment of topiramate at the end of the treatment period | 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. | Month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, Indian, Topiramate