A Phase II Clinical Trial of PRX-00023 Therapy in Localization-Related Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Seizure Frequency in the Active and Placebo Periods
研究概览
简要总结
Background:
- The brain chemical serotonin helps nerve cells communicate. Previous research suggests that serotonin activity may be lower in brain areas where seizures start, and that increasing activity at the serotonin receptor site on nerve cells may help prevent seizures. Researchers are interested in determining whether the experimental medication PRX-00023, which increases the activity of serotonin receptors, can reduce seizure frequency in people whose seizures are not well-controlled on antiseizure medication. PRX-00023 has not previously been studied in people with epilepsy and has not previously been given to people taking antiseizure medication at the same time.
Objectives:
- To evaluate the effectiveness of PRX-00023 in reducing the frequency of epileptic seizures that start from only one part of the brain.
Eligibility:
- Individuals between 18 and 65 years of age who have frequent epileptic seizures even after trying at least two different standard anti-seizure medications (either at the same time or one after the other).
Design:
- The study requires 9 outpatient visits to the NIH Clinical Center over a 34-week period. Individuals who choose to participate in additional studies may be an inpatient during some of these visits.
- Participants will be screened with a medical history and physical examination, blood and urine samples, ECG, EEG, neuropsychological studies, imaging studies, including PET and MRI scans
- Participants will have a 6-week observation and evaluation period before starting the study medication. Participants who have at least four seizures during this period will be eligible for the treatment portion of the study.
- All participants will receive either PRX-00023 or a placebo pill twice daily for 12 weeks, and will have regular clinic visits with blood samples and imaging studies.
- After the 12-week period, participants will have a 2- to 3-week washout period without any study medication.
- Participants will then have another study medication period, and will receive the opposite pill (PRX-00023 or placebo) from the one taken in the first treatment phase. Participants will continue to have regular clinic visits with blood samples, ECG, EEG and neuropsychologicalstudies.
- One month after the end of the second study medication phase, participants will have a followup evaluation with a physical examination, blood tests, ECG, EEG, mood and neuropsychological tests.
Outcome measures:
The primary outcome measure for drug efficacy will be:
Mean difference in seizure frequency comparing the active and placebo periods.
Secondary outcome measures for efficacy will be:
Proportion of patients with greater than or equal to 50% lower seizure rate on PRX-00023 than placebo
Hamilton Depression and Anxiety Rating scales
Performance on mood and neuropsychological testing scales
详细描述
Introduction:
PRX-00023 is a selective 5HT1A agonist being developed as an oral therapeutic treatment for epilepsy.
Objective:
To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the 5HT1A receptor agonist PRX-00023 in patients with localization-related epilepsy. PRX-00023 is a 5HT1A receptor agonist that has shown promise in clinical trials of depression. Patients with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites might ameliorate seizures. Moreover, depression is a common co-morbidity in people with epilepsy. Altered 5HT1A receptor binding has been found in depression.
Study Population:
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
- Double (Participant, Investigator)
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
Placebo Then PRX
Subjects are administered Placebo x3 months followed by PRX (selective 5HT1A agonist) x3 months
干预措施: PRX-00023 (Drug)
Placebo Then PRX
Subjects are administered Placebo x3 months followed by PRX (selective 5HT1A agonist) x3 months
干预措施: Placebo (Drug)
PRX Then Placebo
Subjects are administered PRX (selective 5HT1A agonist) x3 months followed by Placebo x3 months
干预措施: PRX-00023 (Drug)
PRX Then Placebo
Subjects are administered PRX (selective 5HT1A agonist) x3 months followed by Placebo x3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Seizure Frequency in the Active and Placebo Periods
时间窗: Three months
Participants used a seizure calendar to record the number of seizures that occurred during the three month treatment period, i.e., while participants were either on PRX-0023 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
- Number of Participants With > 50% Lower Seizure Rate on PRX-0023.(Three months)
- Mean Score on the Hamilton Anxiety Rating Scale at the End of the Active and Placebo Periods.(Three months)
- Mean Score on the Hamilton Depression Rating Scale at the End of the Active and Placebo Periods(Three months)
- Mean Score on the Hopkins Verbal Learning Test-Revised (HVLT-R) at the End of the Active and Placebo Periods(Three months)
- The Mean Score on the Brief Visuospatial Memory Test-Revised (BVMT-R), at the End of the Active and Placebo Period.(Three months)
- Mean Score on the Columbia Suicide Severity Rating Scale at the End of the Active and Placebo Periods(Three months)
- Results of Clinical Examination of the Nervous System at the End of the Active and Placebo Treatment Periods(Three months)
- Results of Clinical Examination of the Respiratory System at the End of the Active and Placebo Treatment Periods(Three months)
- Results of Clinical Examination of the Cardiovascular System at the End of the Active and Placebo Treatment Periods(Three months)
- Results of Clinical Examination of the Musculoskeletal System at the End of the Active and Placebo Treatment Periods(Three months)
- Number of Subjects With an Abnormal CBC Result at the End of the Active and Placebo Periods(Three months)
- Number of Subjects With Abnormal Clinical Chemistry Labs at the End of the Active and Placebo Periods(Three months)
- Number of Subjects With an Abnormal ECG Result at the End of the Active and Placebo Periods(Three months)