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).
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
209
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.
Number of participants with adverse events
Time frame: Up to 3 months
Number of adverse events
Time frame: Up to 3 months
Number of participants with incidence of discontinuation of study medication
Time frame: Up to 3 months
Reason for participant's discontinuation of study medication
Time frame: Up to 3 months
Change from baseline in the body weight
Time frame: 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.
Time frame: 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.
Time frame: Month 3
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