A Study of Prophylaxis for Migraine Patients With Topiramate in India (PROMPT-IN)

April 17, 2013 updated by: Janssen-Cilag Ltd.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Indian participants experiencing migraine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Topiramate
Drug: No intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to 3 months
Up to 3 months
Number of adverse events
Time Frame: Up to 3 months
Up to 3 months
Number of participants with incidence of discontinuation of study medication
Time Frame: Up to 3 months
Up to 3 months
Reason for participant's discontinuation of study medication
Time Frame: Up to 3 months
Up to 3 months
Change from baseline in the body weight
Time Frame: Baseline (screening) to 3 months
Baseline (screening) to 3 months
Participant's overall assessment of topiramate at the end of the treatment period
Time Frame: 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.
Month 3
Physician's overall assessment of topiramate at the end of the treatment period
Time Frame: 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.
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100585
  • TOPMATMIG4020 (Other Identifier: Janssen-Cilag Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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