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Growth Hormone · 1 trial · 6 indications
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...
Growth Hormone is being studied as a Phase 2 investigational therapy for patients with traumatic brain injury (TBI). The ongoing clinical trial focuses on growth hormone replacement in this population, aiming to address hormone deficiencies that can result from brain injury. It is not yet approved for this use.
Growth Hormone is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the NYSE under the ticker symbol NVO. The company is conducting a Phase 2 clinical trial to evaluate the therapy in patients with traumatic brain injury.
Growth Hormone is currently in Phase 2 clinical development for traumatic brain injury. It is an investigational therapy, meaning it has not been approved by regulatory authorities for this indication. The ongoing trial is actively recruiting participants.
Growth Hormone is being evaluated in one active Phase 2 clinical trial with the identifier NCT04121780. The study, titled 'Growth Hormone Replacement Therapy for Retired Professional Football Players,' is recruiting 42 male participants in the United States and is randomized, double-blind, and placebo-controlled.
Growth Hormone is the general name for the hormone, and the drug being studied is a recombinant form of human growth hormone. In the context of this clinical trial, it refers to the replacement therapy being tested for traumatic brain injury. The trial does not specify a brand name.