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| ID | Type | Description | Link |
|---|---|---|---|
| TOPMATMIG4020 | Other Identifier | Janssen-Cilag Ltd. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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Indian participants experiencing migraine
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd. Clinical Trial | Janssen-Cilag Ltd. | Study Director |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |