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NCT04121780 · ClinicalTrials.gov registry record · Phase 2
Growth Hormone Replacement Therapy for Retried Professional Football Players
A Phase 2 study of TBI (Traumatic Brain Injury) and Concussion, Brain, sponsored by Center for Neurological Studies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT04121780: Recruiting Phase 2 study of TBI (Traumatic Brain Injury) and Concussion, Brain, sponsored by Center for Neurological Studies.
NCT04121780 is a Phase 2 study of TBI (Traumatic Brain Injury) and Concussion, Brain that is actively recruiting participants, run by Center for Neurological Studies. The registered enrollment target is 42 participants, below the 171-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121780, a Phase 2 study of TBI (Traumatic Brain Injury) and Concussion, Brain, is actively recruiting participants, sponsored by Center for Neurological Studies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
To assess change in working memory from base line to 1 yr post-treatment. Working memory will be reported as an index score based on scaled scores for the digit span subtest and symbol span subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Growth Hormone
Study Locations (1)
Michigan
- Center for Neurolgoical Studies (CNS) - Dearborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT04121780 shows while recruiting
NCT04121780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 171-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (75% lower).
The record links to 6 conditions, with TBI (Traumatic Brain Injury) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04121780 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04121780 about?
NCT04121780 is a clinical study titled "Growth Hormone Replacement Therapy for Retried Professional Football Players". 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).
What is the current status of trial NCT04121780?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-10-08. Estimated completion is 2026-09.
What conditions does trial NCT04121780 study?
This clinical trial studies the following conditions: TBI (Traumatic Brain Injury), Concussion, Brain, Growth Hormone Deficiency, Hypopituitarism, Sport Injury.
What interventions are being tested in trial NCT04121780?
The interventions under investigation include: Placebo (OTHER), Growth Hormone (BIOLOGICAL).
Who is sponsoring clinical trial NCT04121780?
This trial is sponsored by Center for Neurological Studies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04121780 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for TBI (Traumatic Brain Injury)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04121780's enrollment target sits among peer trials
42 15th of 20 higher than 5 of 20 other TBI (Traumatic Brain Injury) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other TBI (Traumatic Brain Injury) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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