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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.


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 events

Number 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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