| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04121780 | Growth Hormone Replacement Therapy for Retried Professional Football Players | PHASE2 | RECRUITING | 42 | — | — | Oct 8, 2019 | Sep 1, 2026 | Feb 8, 2023 | 1 | United States |
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.
To assess change in Processing Speed from baseline to 1 yr post-treatment. Processing speed will be reported as an index score based on scaled scores of digit symbol subtest and symbol search 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. Trail Making Test A will also be used to assess processing speed. Reported as T-score. Higher scores reflect better performance.
To assess change in Executive Function from baseline to 1 yr post-treatment. Trail Making Test B and verbal fluency (letter and category) will be used to assess executive function. Reported as T-score. T scores have a mean of 50 and a standard deviation of 10. Scores range from 13 to 87. Higher scores reflect better performance.
To assess change in Verbal learning and memory from baseline to 1 yr post-treatment. California verbal learning test will be used to assess this outcome measure. Reported as a standard score with a mean of 0 and a standard deviation of 1. Scores range from -0.5 to +5.0. Higher scores reflect better performance.
To assess change in ANAM from baseline to 1 yr post-treatment. ANAM Test System- Core Battery will be used to assess this outcome measure. Reported as a standard score
| Arm | Type | Description |
|---|---|---|
| Growth Hormone | EXPERIMENTAL | Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc). |
| Saline | PLACEBO_COMPARATOR | Saline-placebo via auto-injector pens (Haselmeier Inc). |
| Name | Type | Description |
|---|---|---|
| Growth Hormone | BIOLOGICAL | Daily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase |
| Placebo | OTHER | Daily self-injections by subjects: 1-year double-blind phase |
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...