An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduction in migraine pain severity and duration
研究概览
简要总结
The objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.
详细描述
This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase, Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Educational Counseling Training
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have either completed the Double-Blind Phase of CAPSS-271 or discontinued the Double-Blind Phase of CAPSS-271 due to lack of efficacy after a minimum of 2 weeks of maintenance treatment.
- •Must continue to meet the specific inclusion criteria outlined in CAPSS-
- •Female subjects must be premenarchal, surgically sterile (hysterectomy, tubal ligation or otherwise incapable of pregnancy); or practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) at study entry and throughout the study; or hormonal contraceptives for at least a 3-month period prior to the start of the study and throughout the study, or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. In addition, female subjects of childbearing potential must have a negative urine pregnancy test at Open-Label Visit 1 (Day 1).
- •Must be able to read and comprehend written instructions and be willing to complete all headache records and questionnaires as required by the protocol.
- •After full explanation of the study, subjects, or their parent/legally authorized representative(s), must demonstrate their willingness to participate by signing an informed consent form. If applicable, pediatric subjects capable of giving assent must sign the assent form.
排除标准
- •Subjects who have developed a more painful condition than their headache pain.
- •Subjects taking any of the prohibited concomitant medications (See Concomitant Medications section).
- •Subjects who are pregnant.
- •Subjects with liver function tests ³ 2 times the upper limit of the normal range.
- •In the investigator's opinion, subjects with poor compliance during the CAPSS-271 study
结局指标
主要结局
Reduction in migraine pain severity and duration
Reduction of average monthly migraine days
Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
Migraine episode and headache episode frequency
Total headache days
Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)
次要结局
- Cumulative frequency of migraine days and migraine episodes
- Use of acute/abortive medications
- Migraine episode and headache episode frequency
- Total headache days
- Migraine-associated symptoms