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Growth Hormone Deficiency in Mild Traumatic Brain Injury

NCT05660356 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

  • Growth Hormone Treatment
  • Growth Hormone Deficiency
  • Concussion, Mild
  • Concussion Post Syndrome

Interventions

DRUG

Growth Hormone

Pfizer provided GH therapy

DRUG

Placebo

Pfizer provided placebo

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Calgary

    lead OTHER

Principal Investigators

  • Chantel T Debert, MD, MSc · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-02-29
Completion
2025-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660356 on ClinicalTrials.gov