hCG Treatment for Rehabilitation From a TBI

Study acronym: COGNI-REHAB
StatusNot Yet Recruiting
PhaseEarly Phase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 1, 2029 → Oct 1, 2029
See other at-risk trials from VA Office of Research and Development

Record History

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  1. Re-verified, no change to tracked fields
  2. Start date: Oct 1, 2026 to Jan 1, 2027 Show 5 more changesShow less
    • Primary completion pushed from Jul 1, 2029 to Oct 1, 2029
    • Study completion pushed from Sep 30, 2029 to Dec 31, 2029
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 6 of 8 entries
    • Publications: details revised at 1 of 1 entry
  3. Site contact updated
    • Eligibility criteria shortened, about 2 words
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07557615
Lead Sponsor VA Office of Research and Development
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov