Growth Hormone Deficiency Clinical Trial
Official title:
Growth Hormone Deficiency in Patients With Persistent Symptoms Following Concussion
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | February 2025 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Pfizer |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | Baseline RBANS | Repeatable Battery for the Assessment of Neuropsychological Status. A higher score indicates better outcomes. | Minimum 6-months following injury (no maximum) | |
Secondary | 3-months RBANS | Repeatable Battery for the Assessment of Neuropsychological Status. A higher score indicates better outcomes. | 3-months after baseline | |
Secondary | Baseline GAD-7 | General Anxiety Disorder 7. A higher score indicates worse outcomes. | Minimum 6-months following injury (no maximum) | |
Secondary | 3-months GAD-7 | General Anxiety Disorder 7. A higher score indicates worse outcomes. | 3-months after baseline | |
Secondary | Baseline PHQ-9 | Personal Health Questionnaire 9. A higher score indicates worse outcomes. | Minimum 6-months following injury (no maximum) | |
Secondary | 3-months PHQ-9 | Personal Health Questionnaire 9. A higher score indicates worse outcomes. | 3-months after baseline | |
Secondary | Baseline RPQ | Rivermead Post-Concussion Symptom Questionnaire. A higher score indicates worse outcomes. | Minimum 6-months following injury (no maximum) | |
Secondary | 3-months RPQ | Rivermead Post-Concussion Symptom Questionnaire. A higher score indicates worse outcomes. | 3-months after baseline | |
Secondary | Baseline QoLIBRI | Quality of Life after Brain Injury. A higher score indicates better outcomes. | Minimum 6-months following injury (no maximum) | |
Secondary | 3-months QoLIBRI | Quality of Life after Brain Injury. A higher score indicates better outcomes. | 3-months after baseline | |
Secondary | Baseline Sleep and Concussion Questionnaire | Sleep and Concussion Questionnaire. A higher score indicates worse outcomes. | Minimum 6-months following injury (no maximum) | |
Secondary | 3-months Sleep and Concussion Questionnaire | Sleep and Concussion Questionnaire. A higher score indicates worse outcomes. | 3-months after baseline |
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