Trials / Completed
CompletedNCT01836874
A Study of Prophylaxis for Migraine Patients With Topiramate in India
Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 209 (actual)
- Sponsor
- Janssen-Cilag Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2008-07-01
- Completion
- 2008-07-01
- First posted
- 2013-04-22
- Last updated
- 2013-04-22
Source: ClinicalTrials.gov record NCT01836874. Inclusion in this directory is not an endorsement.