A Phase Two Clinical Trial of Buspirone Therapy in Localization-Related Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Seizure Frequency in the Buspirone (Active) and Placebo Periods
研究概览
简要总结
Background:
Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest that buspirone might act on parts of the brain that can increase certain levels of brain activity. Increasing this brain activity may help decrease epileptic seizures that come from certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency in people with seizures who are already taking antiseizure medication.
Objectives:
To test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain.
Eligibility:
Individuals between 18 and 65 years of age who have seizures coming from one or more places in the brain.
Participants must have tried at least two different antiseizure medications.
Participants must also have had at least three seizures during a 1-month observation period while on current medicines.
Design:
Participants will have a screening visit with a physical exam and medical history. Participants will complete mood and memory testing scales. Blood, urine, and saliva samples will be collected.
Participants will have a magnetic resonance imaging scan to evaluate brain structures that relate to epilepsy. They will also have a positron emission tomography scan to look at parts of the brain that are affected by buspirone.
Participants will start taking a study drug (either buspirone or placebo) twice daily. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples.
After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.
After 2 weeks, participants will start taking a study drug that is the opposite of the one they had before. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples.
After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone.
Participants will have a final followup visit with additional blood tests, mood and memory testing scales and imaging studies.
详细描述
OBJECTIVE:
To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the 5HT1A receptor agonist buspirone in patients with localization-related epilepsy. Buspirone is a 5HT1A receptor agonist that is approved for the treatment of anxiety disorders. Patients with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites may ameliorate seizures.
STUDY POPULATION:
Forty patients with localization-related epilepsy
DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Study Phase
干预措施: Buspirone (Drug)
Alternate Study Phase
干预措施: Placebo (Drug)
结局指标
主要结局
Seizure Frequency in the Buspirone (Active) and Placebo Periods
时间窗: Three months
Participants utilized a seizure calendar to record the number of seizures that occurred during the three month treatment period, i.e., while participants were either taking Buspirone or Placebo. Seizure frequency was calculated as the total number of seizures occurring during each three month period. For each period a mean was calculated across subjects.
次要结局
- Mean Score on the Hamilton Depression Rating Scale (HAM-D) at the End of the Active and Placebo Periods(Three months)
- Mean Score on the Beck Depression Inventory (BDI) at the End of the Active and Placebo Periods(Three months)
- Mean Score on the Cancellation Task Following 3 Months on Active Drug and 3 Months on Placebo(Three months)
- Mean Score on the Trail Making Test-B (TMT-B) Following 3 Months on Active Drug and 3 Months on Placebo(Three months)
- Mean Score on the Hamilton Anxiety Rating Scale (HAM-A) at the End of the Active and Placebo Periods.(Three months)
- Mean Score on the Trail Making Test-A (TMT-A) Following 3 Months on Active Drug and 3 Months on Placebo(Three months)