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New treatment option for TBI (Traumatic Brain Injury)
Official title Growth Hormone Replacement Therapy for Retried Professional Football Players
ClinicalTrials.gov ID: NCT04121780
What this study is testing
What is Growth Hormone?
Growth Hormone is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for tbi (traumatic brain injury).
Also referred to as Norditropin® (somatropin [rDNA origin] injection).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 76, men only
You may be able to join if
- The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
- people who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
The study team makes the final eligibility decision.
Where it's taking place
- Dearborn, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 76 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dearborn, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.