Migraine
Conditions
Keywords
Migraine, Indian, Topiramate
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.
Interventions
DRUGNo 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.
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | Up to 3 months | — |
| Number of adverse events | Up to 3 months | — |
| Number of participants with incidence of discontinuation of study medication | Up to 3 months | — |
| Reason for participant's discontinuation of study medication | Up to 3 months | — |
| Change from baseline in the body weight | Baseline (screening) to 3 months | — |
| Participant's overall assessment of topiramate at the end of the treatment period | 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. |
| Physician's overall assessment of topiramate at the end of the treatment period | 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. |
Outcome results
None listed