Chorionic Gonadotropin to Improve Rehabilitation After Brain Injury - The COGNI-REHAB Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent change in Treatment-Emergent Adverse Events
研究概览
简要总结
The COGNI-REHAB Trial is a single-site, phase O/I, randomized, double-blind, placebo-controlled study of human chorionic gonadotropin (hCG; choriogonadotropin alfa, Ovidrel®) in men with post-acute, moderate to severe traumatic brain injury (msTBI). Its objective is to assess the safety and efficacy of a 24-week regimen of Ovidrel (125 micrograms twice weekly) compared to placebo on treatment-emergent adverse events (TEAEs), cognitive and functional recovery, and circulating sex hormones.
详细描述
This project aims to re-purpose a safe, well-tolerated, already-approved medication: human chorionic gonadotropin (hCG; choriogonadotropin alfa, Ovidrel®) for use in the post-acute rehabilitation of moderate to severe traumatic brain injury (msTBI). Ovidrel is currently FDA-approved for use in ovulation induction and Assisted Reproductive Technologies (ART). The rationale for using Ovidrel comes from a convergence of evidence indicating that hCG has neurodevelopmental and neuroregenerative properties, and from preclinical studies demonstrating that hCG reverses TBI-induced suppression of sex hormone production (i.e., reverses hypogonadism) and improves recovery of sensorimotor and spatial learning and memory in rodents following a focal injury to the medial prefrontal cortex. Recovery from a TBI is typically a very slow process because innate neuronal regeneration is a slow process; thus, Ovidrel (125 µg twice weekly) treatment will be evaluated over 24-weeks in patients that are 1-6 months post-TBI.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged 18-65
- •Subject is 1-month but < 6-month post-TBI with a msTBI defined as Glasgow Coma Scale (GCS) 4-12 (inclusive) at the time of the TBI, and/or at the time of screening (Visit 1)
- •Stable doses of any medication, supplement or medical food that may affect brain function, unless deemed medically necessary by the patient's physician for optimal healthcare
- •Fluent in English
- •Reasonable expectation of availability to receive the 24-week course of therapy and be available for follow up evaluations
排除标准
- •Significantly depressed (Geriatric Depression Scale > 10)
- •Patients considered to be at risk for suicidality or homicidality according to the Columbia Suicide Severity Rating Scale (CSSRS)
- •Primary hypogonadism (unrelated to trauma)
- •Renal disease; Asthma; known endocrine or germ cell tumor
- •Taking other medications known to affect serum sex hormone or gonadotropin concentrations such as testosterone for hormone replacement therapy, goserelin or danazol, in the past three (3) months
- •Presence of significant systemic illness likely to interfere with participation in or completion of the study or to affect study results
- •Receiving other investigational drugs within 30 d or 5 half-lives prior to randomization, whichever longer
- •Male patients with known/documented elevated PSA levels, or a PSA level of 4ng/mL at screening
- •History of deep venous thrombosis (DVT) or venous thromboembolism (VTE)
- •Clinically significant peripheral edema
- •History of sleep apnea
- •Severe symptoms of benign prostatic hyperplasia (BPH), i.e., International Prostate Symptom Score greater than or equal to 20 points
- •Patients with known hypercoagulability, including cardiolipin/antiphospholipid antibody syndrome
- •Allergy or other contraindication to hCG
- •Uncontrolled hypertension, defined as blood pressure persistently above 140 mm Hg systolic or 95 mm Hg diastolic despite antihypertensive therapy
- •Uncontrolled thyroid, adrenal or pituitary dysfunction
- •An uncontrolled organic intracranial lesion such as a pituitary tumor
- •History of breast or prostate cancer; sex hormone dependent tumors of the reproductive organs or accessory sex glands
- •Taking hCG, or any condition known to elevate hCG, active in the prior 24 mo. e.g., choriocarcinoma or germ cell tumor
- •Patients who have 6 or more symptoms for substance use disorder according to DSM-5 criteria
- •Patients with evidence of an active or previous thrombotic event
研究组 & 干预措施
Treatment Arm
Ovidrel: 125 micrograms in 0.25 mL administered subcutaneously twice weekly for 24 weeks
干预措施: Ovidrel (Drug)
Placebo Arm
Placebo: 0.25 mL of sterile normal saline administered subcutaneously twice weekly for 24 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Percent change in Treatment-Emergent Adverse Events
时间窗: Baseline, 26 Weeks
The frequency and type of individual TEAEs, discontinuations due to TEAEs, serious TEAEs, and clinically significant changes in laboratory test values.
次要结局
- Percent change in modified Functional Independence Measure (FIM)(Baseline, 24 Weeks)
- Glasgow Outcome Scale-Extended (GOSE)(Baseline, 24 Weeks)
- Percent Change in Neuropsychiatric Inventory (NPI)(Baseline, 24 Weeks)
- Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)(Baseline, 24 Weeks)
- Percent change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(Baseline, 24 Weeks)
- Percent change in Automated Neuropsychological Assessment Metrics Military (ANAM)(Baseline, 24 Weeks)
- Percent change in Trail Making Test (TMT)(Baseline, 24 Weeks)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, 26 Weeks)