hCG Treatment for Rehabilitation From a TBI

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.

Timeline

Start

2026-10-01

Primary completion

2029-07-01

Completion

2029-09-30

Publications

• Background 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.

Drugs

Indications