Status:
RECRUITING
Growth Hormone Replacement Therapy for Retried Professional Football Players
Lead Sponsor:
Center for Neurological Studies
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
TBI (Traumatic Brain Injury)
Concussion, Brain
Eligibility:
MALE
18-76 years
Phase:
PHASE2
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...
Detailed Description
GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04121780
Start Date
October 8 2019
End Date
September 1 2026
Last Update
February 8 2023
Active Locations (1)
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1
Center for Neurolgoical Studies (CNS)
Dearborn, Michigan, United States, 48126