hCG Treatment for Rehabilitation From a TBI

NCT07557615 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: RRD1-026-25M14343177
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Human chorionic gonadotropin

Outcome Measures

Primary Outcomes (1)

• Percent change in Treatment-Emergent Adverse Events

  The frequency and type of individual TEAEs, discontinuations due to TEAEs, serious TEAEs, and clinically significant changes in laboratory test values.

  Baseline, 26 Weeks

Secondary Outcomes (8)

• 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

Other Outcomes (1)

• Change in Circulating Sex Hormone Concentrations

  Baseline, 26 Weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Ovidrel: 125 micrograms in 0.25 mL administered subcutaneously twice weekly for 24 weeks

Drug: Ovidrel

Placebo Arm

PLACEBO COMPARATOR

Placebo: 0.25 mL of sterile normal saline administered subcutaneously twice weekly for 24 weeks

Other: Placebo

Interventions

Ovidrel DRUG

Ovidrel, recombinant human chorionic gonadotropin, comes in a prefilled syringe for subcutaneous injection, is the investigational agent that will be used in this trial. Ovidrel® PreFilled Syringe is a sterile, liquid intended for subcutaneous (s.c.) injection. Each Ovidrel® PreFilled Syringe is filled with 0.515 mL containing 257.5 micrograms of choriogonadotropin alfa, 28.1 mg mannitol, 505 g 85% O-phosphoric acid, 103 g L-methionine, 51.5 g Poloxamer 188, Sodium Hydroxide (for pH adjustment), and Water for Injection to deliver 125 micrograms of choriogonadotropin alfa in 0.25 mL twice weekly. The pH of the solution is 6.5 to 7.5.

Also known as: Choriogonadotropin alfa

Treatment Arm

Placebo OTHER

Prefilled syringe of 0.250 mL normal saline.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

Location

Related Publications (1)

• Geddes RI, Kapoor A, Hayashi K, Rauh R, Wehber M, Bongers Q, Jansen AD, Anderson IM, Farquhar G, Vadakkadath-Meethal S, Ziegler TE, Atwood CS. Hypogonadism induced by surgical stress and brain trauma is reversed by human chorionic gonadotropin in male rats: A potential therapy for surgical and TBI-induced hypogonadism? Endocrinol Diabetes Metab. 2021 Mar 18;4(3):e00239. doi: 10.1002/edm2.239. eCollection 2021 Jul.

  PMID: 34277964 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Ovidrel; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Craig Atwood, PhD

  William S. Middleton Memorial Veterans Hospital, Madison, WI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig Atwood, PhD

CONTACT

(608) 280-7000; Craig.Atwood@va.gov

Robert Kotloski, MD

CONTACT

(608) 825-1901; robert.kotloski@va.gov

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Placebo controlled.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Research data and results that document and support the study aims will be available after the final results are accepted for publication.
• Access Criteria: Approval from PI

Locations

US (1)