Clinical trial NCT01836874: A Study of Prophylaxis for Migraine Patients With Topiramate in India
Official title: Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Migraine
Indian
Topiramate
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indian participants experiencing migraine

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.

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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 3 months
measure: Number of adverse events
timeFrame: Up to 3 months
measure: Number of participants with incidence of discontinuation of study medication
timeFrame: Up to 3 months
measure: Reason for participant's discontinuation of study medication
timeFrame: Up to 3 months
measure: Change from baseline in the body weight
timeFrame: Baseline (screening) to 3 months
measure: Participant's overall assessment of topiramate at the end of the treatment period
timeFrame: Month 3
measure: Physician's overall assessment of topiramate at the end of the treatment period
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: