Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Augmentation severity scale
研究概览
简要总结
This is an exploratory, double blinded cross-over study of the D1 antagonist ecopipam treat patients currently having dopamine agonist induced augmentation in restless legs syndrome. Each arm is 6 weeks composed of an unforced titration up to 100mg/day separated by a 2-week wash-out period. Efficacy points will include the IRLS, augmentation scales, sleep scales, clinical impressions and fatigue/mood scales.
详细描述
This is a double-blind, exploratory proof of concept, cross-over trial of the D1 antagonist ecopipam for subjects with augmented Restless legs syndrome (RLS). Investigators will recruit 10 subjects taking dopamine agonists for RLS who are currently experiencing augmentation. The goal is to have 8 completers. There is no power analysis as this is an exploratory study and there is no previous data on treatment of augmentation. "Meaningful improvement" is not even established. A safety analysis will be done after 5 subjects have been enrolled. Duration of study and is based mostly on contracted drug availability for this pilot study.
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)
盲法说明
placebo
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide consent to participate in the study
- •Individuals of either sex, 21-80 years of age
- •Clinically defined Restless Leg Syndrome, and problematic augmentation currently on monotherapy with dopaminergic treatment.
排除标准
- •Current use of Opioid medications
- •Clinical relevant depression or other medical problems that in the opinion of the investigator would not allow for safe completion of the protocol.
- •Suicidal ideation
- •History of epilepsy
- •Current MAO inhibitors
研究组 & 干预措施
Study period 1
- Ecopipam or matching placebo 25 mg by mouth for 7 days (week 1), followed by
- Ecopipam or matching placebo 50 mg by mouth for 7 days (week 2), followed by
- Ecopipam or matching placebo 100 mg by mouth for 23 days (weeks 3).
干预措施: Placebo (Drug)
Study period 2
- Matching placebo or ecopipam 25 mg by mouth for 7 days (week 7), followed by
- Matching placebo or ecopipam 50 mg by mouth for 7 days (week 8), followed by
- Matching placebo or ecopipam 100 mg by mouth for 23 days (week 9).
干预措施: Placebo (Drug)
Study period 1
- Ecopipam or matching placebo 25 mg by mouth for 7 days (week 1), followed by
- Ecopipam or matching placebo 50 mg by mouth for 7 days (week 2), followed by
- Ecopipam or matching placebo 100 mg by mouth for 23 days (weeks 3).
干预措施: Ecopipam (Drug)
Study period 2
- Matching placebo or ecopipam 25 mg by mouth for 7 days (week 7), followed by
- Matching placebo or ecopipam 50 mg by mouth for 7 days (week 8), followed by
- Matching placebo or ecopipam 100 mg by mouth for 23 days (week 9).
干预措施: Ecopipam (Drug)
结局指标
主要结局
Augmentation severity scale
时间窗: baseline to end of each treatment arm (6 weeks)
scale
International RLS Rating scale
时间窗: baseline to end of each treatment arm (6 weeks)
scale
Change From Baseline (Predose) in Mean International Restless Legs Syndrome (IRLS) Rating Scale at End of Intervention Period
时间窗: Baseline (Pre-intervention), and at 5 weeks
IRLS scale is a patient-administered test that measures the severity of restless legs syndrome symptoms. The IRLS scale consists of 10 questions rated from 0 to 4. The total score on symptom severity range from 0 (none) to 40 (worst).
Change From Baseline in Mean Body Part Affected by RLS Symptoms Using Augmentation Severity Rating Scale (ASRS)
时间窗: Baseline (Pre-intervention), and at 5 weeks
ASRS scale has three items and probes symptoms over the past week. The first item asks the time at which symptoms began in the last week. The second item probes how quickly symptoms begin when sitting at various times of the day during the past week, and the third item probes which body parts were involved in the past week. Each item has a total of 8 points for a 24-point total scale. 0 is no augmentation and 24 is the most severe augmentation. In the third item, participants are asked to shade in the figure the portions of his/her body affected by RLS symptoms for a total of 8 points. The higher the score the worse the outcome
次要结局
- 24 hour RLS diary(Day 0 (visit 1) to end of each treatment arm (6 weeks))
- Clinical Global Impression(From start of each treatment arm through one week after treatment withdrawal)
- Mean 24 Hour Restless Legs Syndrome (RLS) Diary at End of Intervention(at end of intervention Ecopipam, at end of intervention Placebo)
- Number of Participants With Effect on the Clinical Global Impression Scale at the End of the Intervention(At end of intervention Ecopipam, at end of intervention Placebo)
研究者
William Ondo, MD
Principal Investigator
The Methodist Hospital Research Institute