Prophylaxis of Migraine Patients With Topiramate in India (PROMPT-IN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Topiramate
干预措施: No intervention (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 3 months
Number of adverse events
时间窗: Up to 3 months
Number of participants with incidence of discontinuation of study medication
时间窗: Up to 3 months
Reason for participant's discontinuation of study medication
时间窗: Up to 3 months
Change from baseline in the body weight
时间窗: Baseline (screening) to 3 months
Physician's overall assessment of topiramate at the end of the treatment period
时间窗: 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.
Participant's overall assessment of topiramate at the end of the treatment period
时间窗: 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.
次要结局
未报告次要终点