Feasibility of Early Gabapentin as an Intervention for Neurorecovery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.
详细描述
Gabapentin is a medication commonly used in spinal cord injury (SCI) to manage neuropathic pain. Emerging preclinical and clinical evidence suggests that early initiation of low to medium doses of gabapentin and continued delivery for a range of 2 weeks to 4 months has a persistent, positive effect on motor and autonomic neurologic recovery. The objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the early administration of gabapentin as an intervention for neurorecovery. A mock efficacy design will be employed. Participants will be stratified based on ASIA Impairment Scale (AIS) grade A-B or C-D and randomized to 1 of 3 arms. Study medication will be initiated within 5 days post-injury and administered for 90 days. Participants will be followed for an additional 90 days after stopping treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Traumatic SCI;
- •All levels of SCI;
- •All severities of SCI, AIS A-D;
- •Age 18 years and older.
- •Agree to participate and start study drug within 120 hours' post-injury.
- •Adequate cognition and communication to provide informed consent
排除标准
- •Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) < 13 at 120 hours' post-injury.
- •Documented use of gabapentinoids at the time of injury.
研究组 & 干预措施
Low dose
600mg treatment group will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
干预措施: Gabapentin (Drug)
Medium dose
1800 mg treatment groups will receive 2 capsules of gabapentin by mouth 3 times per day for 90 days.
干预措施: Gabapentin (Drug)
Control
The control group will receive 2 placebo capsules of inert cellulose by mouth 3 times per day for 90 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Retention rate
时间窗: Across 6 month study duration per participant
Feasibility question - Will participants complete the study? Feasibility measure - Retention rate; reasons for dropout; proportion of planned assessments completed Quantitative benchmark of success - 70% of participants stay enrolled until the end of the study and complete 3 of the 4 assessment visits
Number of participants recruited
时间窗: During the first 120 hours post-injury
Feasibility question - Can the target population be recruited? Feasibility measure - Number screened/month; number enrolled/month; reasons for not enrolling Quantitative benchmark of success - Screen an average of 4/month; Enroll an average of 1/month
Adherence rate to drug treatment protocol
时间窗: Across 90 day treatment window
Feasibility question - Can the drug treatment protocol be delivered? Feasibility measure - Proportion of enrolled who receive the full drug treatment protocol (placebo arm; two gabapentin dose arms); number of dosing deviations/arm; reasons for dosing deviations Quantitative benchmark of success - 70% enrolled in placebo arm receive full dosing protocol; 70% enrolled in each gabapentin arm receive full dosing protocol
Number of occurrences of unblinding
时间窗: Across 6 month study duration per participant
Feasibility question - Can the assessors remain blinded? Feasibility measure - Number of occurrences of unblinding; reasons for unblinding Quantitative benchmark of success - 5% or fewer occurrences of unblinding
次要结局
未报告次要终点
研究者
Kimberly Anderson, PhD
Director, Northeast Ohio Regional SCI Model System
MetroHealth Medical Center