Recruiting
Phase 2

Growth Hormone

Sponsor:

Center for Neurological Studies

Code:

NCT04121780

Conditions

TBI (Traumatic Brain Injury)

Concussion, Brain

Sport Injury

Anterior Pituitary Hyposecretion Syndrome

Hypopituitarism

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Growth Hormone

Placebo

Study Details

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 football players with growth hormone deficiency (GHD).

Conditions

TBI (Traumatic Brain Injury)

Concussion, Brain

Sport Injury

Anterior Pituitary Hyposecretion Syndrome

Hypopituitarism

Study ID

NCT04121780

Start date

Oct 8, 2019

Status verified date

Feb, 2023

Completion date

Sep, 2026

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 76 years of age
  • Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD

Exclusion Criteria:

  • 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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Growth Hormone

Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).

placebo comparator: Saline

Saline-placebo via auto-injector pens (Haselmeier Inc).

Interventions

Growth Hormone

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

Daily self-injections by subjects:

1-year double-blind phase

Primary outcome measure

  • Cognitive functions- Working Memory [ Time Frame: From baseline to 1-year post-treatment ]
  • Cognitive functions- Processing Speed [ Time Frame: From baseline to 1-year post-treatment ]
  • Cognitive functions- Executive Function. [ Time Frame: From baseline to 1-year post-treatment ]
  • Cognitive functions- Verbal learning and memory [ Time Frame: From baseline to 1-year post-treatment ]
  • Cognitive functions- ANAM ( Automated Psychological Assessment Metrics) [ Time Frame: From baseline to 1-year post-treatment ]

Central Contacts and Locations

Central contacts

Vijay M Baragi, Ph.D.

313-228-0930.vijay@neurologicstudies.com

John Russell

3132280930JDR@neurologicstudies.com

Locations

Center for Neurolgoical Studies (CNS)

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Vijay Baragi, Ph.D.

313-228-0930vijay@neurologicstudies.com

John Russell

3132280930JDR@neurologicstudies.com

More Information

Sponsor

Center for Neurological Studies

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

  • TBI
  • GHD
  • Growth Hormone
  • Norditropin Flexpro
  • cognition disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Neurological Studies on 2023-02-08.