Overview

Growth Hormone Deficiency in Mild Traumatic Brain Injury

Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this randomized control trial is to test if growth hormone therapy is a safe and effective treatment for patients suffering from growth hormone deficiency and persistent post-concussion symptoms. The main questions it aims to answer are: 1. Is growth hormone therapy effective at mitigating persisting post-concussion symptoms in patients with growth hormone deficiency? 2. Is it feasible to conduct a larger trial to examine efficacy of growth hormone therapy in patients with persistent post-concussion symptoms and growth hormone deficiency? Participants will be asked to complete an initial assessment for study inclusion and to complete clinical outcome questionnaires. If a participant meets study criteria they will be randomized to receive either growth hormone therapy (provided by Pfizer) or a placebo (provided by Pfizer). Participants will be instructed on how to self-administer their assigned drug daily for three months. Monthly follow-up visits will include a blood draw to measure a biomarker and clinical outcome questionnaires. At the final follow-up visit after three months, participants will learn what group they were assigned and given the option to complete the growth hormone therapy if they were originally assigned to the placebo group. Researchers will compare the growth hormone therapy group to the placebo group to identify any potential differences in outcomes.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Calgary
Collaborator:
Pfizer
Treatments:
Hormones
Criteria
Inclusion Criteria:

- Sustained a concussion according to the American Congress of Rehabilitation Medicine
criteria with persistent symptoms 6-months following concussion

- Peak growth hormone of < 3 mcg/L following glucagon stimulation test

Exclusion Criteria:

- Untreated pituitary dysfunction

- Moderate/severe TBI

- Intracranial abnormalities

- Chronic neurologic conditions