Growth Hormone Deficiency in Mild Traumatic Brain Injury

NCT05660356 | Unknown Early Phase 1

• 1 other identifier: REB22-1684
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Is growth hormone therapy effective at mitigating persisting post-concussion symptoms in patients with growth hormone deficiency?
2. 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?

Conditions

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

Keywords

Growth Hormone Deficiency; Persistent Post-concussion Symptoms; Growth Hormone Therapy; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Baseline QoL-AGHDA

  Adult Growth Hormone Deficiency Assessment Quality of Life Questionnaire. A high score indicates a lower quality of life.

  Minimum 6-months following injury (no maximum)

• 3-months QoL-AGHDA

  Adult Growth Hormone Deficiency Assessment Quality of Life Questionnaire. A high score indicates a lower quality of life.

  3-months after baseline

Secondary Outcomes (12)

• Baseline RBANS

  Minimum 6-months following injury (no maximum)

• 3-months RBANS

  3-months after baseline

• Baseline GAD-7

  Minimum 6-months following injury (no maximum)

• 3-months GAD-7

  3-months after baseline

• Baseline PHQ-9

  Minimum 6-months following injury (no maximum)

Study Arms (2)

Growth Hormone

EXPERIMENTAL

Participants will perform daily at-home subcutaneous GH injections after receiving thorough at-home education training provided by a pharmaceutical nurse before and research personnel. The GH will be provided be Pfizer. Starting doses will be 0.2 ug/L and 0.3 ug/L for women taking exogenous oral estrogen.

Drug: Growth Hormone

Placebo

PLACEBO COMPARATOR

Participants will perform daily at-home subcutaneous placebo injections after receiving thorough at-home education training provided by a pharmaceutical nurse before and research personnel. Starting doses will be 0.2 ug/L and 0.3 ug/L for women taking exogenous oral estrogen.

Drug: Placebo

Interventions

Growth Hormone DRUG

Pfizer provided GH therapy

Also known as: Growth Hormone Therapy

Growth Hormone

Placebo DRUG

Pfizer provided placebo

Also known as: Placebo (no active therapy)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Untreated pituitary dysfunction
• Moderate/severe TBI
• Intracranial abnormalities
• Chronic neurologic conditions

Sponsors & Collaborators

• University of Calgary: lead
• Pfizer: collaborator

Related Publications (1)

• Mercier LJ, Kruger N, Le QB, Fung TS, Kline GA, Debert CT. Growth hormone deficiency testing and treatment following mild traumatic brain injury. Sci Rep. 2021 Apr 20;11(1):8534. doi: 10.1038/s41598-021-87385-7.

  PMID: 33879807 RESULT

MeSH Terms

Conditions

Dwarfism, Pituitary; Brain Concussion; Post-Concussion Syndrome

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Brain Injuries, Traumatic; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chantel T Debert, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantel T Debert, MD, MSc

CONTACT

4039444500; cdebert@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to their assigned group. Following completion of the study, participants will be informed of their group allocation and be given the option to complete the treatment group if they were originally assigned to the placebo group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic Physiatrist

Model Details: Treatment group and placebo group. Participants assigned placebo group will be given the option to complete...

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share