NCT04121780 Growth Hormone Replacement Therapy for Retried Professional Football Players
| NCT ID | NCT04121780 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Center for Neurological Studies |
| Condition | TBI (Traumatic Brain Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2019-10-08 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2019-10-08 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).
Eligibility Criteria
Inclusion Criteria: * The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study. * Former NFL player * At least one year since retirement from football * Less than 76 years of age * Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD Exclusion Criteria: * History of pre-existing brain disease other than concussion or TBI * History of a premorbid disabling condition that interferes with outcome assessments * Contraindication to GH therapy * Type I and II Diabetes mellitus * Active malignant disease * Acute critical illness, heart failure, or acute respiratory failure * Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Contact & Investigator
Randall R Benson, MD
PRINCIPAL INVESTIGATOR
Vice President and Medical Director
Frequently Asked Questions
Who can join the NCT04121780 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 76 Years, studying TBI (Traumatic Brain Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04121780 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04121780 currently recruiting?
Yes, NCT04121780 is actively recruiting participants. Contact the research team at vijay@neurologicstudies.com for enrollment information.
Where is the NCT04121780 trial being conducted?
This trial is being conducted at Dearborn, United States.
Who is sponsoring the NCT04121780 clinical trial?
NCT04121780 is sponsored by Center for Neurological Studies. The principal investigator is Randall R Benson, MD at Vice President and Medical Director. The trial plans to enroll 42 participants.