hCG Treatment for Rehabilitation From a TBI

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.

Inclusion Criteria: * Subject is 1-month but \< 6-month post-traumatic brain injury (TBI) with a moderate to severe traumatic brain injury (msTBI) defined as Glasgow Coma Scale (GCS) 4-12 (inclusive) at the time of the traumatic brain injury (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 Exclusion Criteria: * 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 human chorionic gonadotropin (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 human chorionic gonadotropin (hCG), or any condition known to elevate human chorionic gonadotropin (hCG), active in the prior 24 months, 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