hCG Treatment for Rehabilitation From a TBI

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
VA Office of Research and Development
Study ID
NCT07557615
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • Placebo — OTHER
    Prefilled syringe of 0.250 mL normal saline.

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Jul 1, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Ovidrel: 125 micrograms in 0.25 mL administered subcutaneously twice weekly for 24 weeks
  • Placebo Comparator: Placebo Arm
    Placebo: 0.25 mL of sterile normal saline administered subcutaneously twice weekly for 24 weeks

Primary Outcome Measure

Percent change in Treatment-Emergent Adverse Events [ Time Frame: Baseline, 26 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
William S. Middleton Memorial Veterans Hospital, Madison, WIMadisonWisconsin53705-2254
Jenna W Quinto, PhD
[email protected]
(680) 256-1901
Aaron F Heneghan, PhD
[email protected]
(608) 256-1901
Craig Atwood, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madison, WI

By research site
William S. Middleton Memorial Veterans Hospital, Madison, WI· Madison, WI

Related Studies