Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)

NCT02114775 | Completed Phase 1

• 1 other identifier: 13-0324
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal is to determine whether perceptual or performance fatigue can be reduced in MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover fashion based upon GH status. A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.

Conditions

Traumatic Brain Injury

Keywords

mild traumatic brain injury; growth hormone; fatigue; sildenafil; neurology

Outcome Measures

Primary Outcomes (8)

• Performance fatigue as measured by using hand grip dynamometry at baseline

  Hand grip exercises will be used to measure performance fatigue at baseline

  baseline

• Performance fatigue as measured by using hand grip dynamometry at 3 months

  Hand grip exercises will be used to measure performance fatigue after 3 months of study intervention

  3 months

• Performance fatigue as measured by using hand grip dynamometry at 6 months

  Hand grip exercises will be used to measure performance fatigue after 6 months of study intervention

  6 months

• Performance fatigue as measured by using hand grip dynamometry at 12 months

  Hand grip exercises will be used to measure performance fatigue after 12 months of study intervention

  12 months

• Performance fatigue as measured by using leg dynamometry at baseline

  Leg exercises will be used to measure performance fatigue at baseline

  baseline

• Performance fatigue as measured by using leg dynamometry at 3 months

  Leg exercises will be used to measure performance fatigue after 3 months of study intervention.

  3 months

• Performance fatigue as measured by using leg dynamometry at 6 months

  Leg exercises will be used to measure performance fatigue after 6 months of study intervention.

  6 months

• Performance fatigue as measured by using leg dynamometry at 12 months

  Leg exercises will be used to measure performance fatigue after 12 months of study

  12 months

Study Arms (2)

Recombinant Growth Hormone

ACTIVE COMPARATOR

Double blind placebo/Genotropin cross over design for 6 months with cross over at 3 months. Then open label Genotropin from month 6 - 12.

Drug: Growth Hormone; Drug: Placebo

Sildenafil

ACTIVE COMPARATOR

Double blinded placebo/Sildenafil crossover design for 6 months with crossover at month 3. Then open label Sildenafil from months 6-12.

Drug: Sildenafil; Drug: Placebo

Interventions

Growth Hormone DRUG

0.4 mg/day injected subcutaneously for one month then increased to 0.6 mg/day for two months during crossover phase. After crossover phase, 0.6 mg/day for six months

Also known as: Genotropin

Recombinant Growth Hormone

Sildenafil DRUG

50 mg by mouth daily

Also known as: Viagra

Sildenafil

Placebo DRUG

Placebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study

Recombinant Growth Hormone; Sildenafil

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female with a diagnosis of mild TBI and 6 month post-injury. Age 18 to 60 years. Complaint of fatigue, with score of 3 or greater on questions 1, 2, or 3 of the Brief Fatigue Inventory.

You may not qualify if:

• Significant heart, liver, kidney, blood or respiratory disease.
• Active coronary disease.
• Pregnancy.
• Alcohol or drug abuse.
• Unable to walk unassisted.
• Diabetes mellitus and anterior pituitary abnormalities diagnosed upon screening.
• Premorbid history of psychiatric disorder.
• Premorbid history of head trauma.
• Use of nitrates.
• Use of alpha blockers.
• Systolic blood pressure \<100 or \>150, diastolic blood pressure \<60 or \>90. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110).
• Peripheral vascular disease.
• Use of a phosphodiesterase 5 inhibitor.
• Coumadin because of the risk of bleeding with daily injections of Recombinant Human Growth Hormone (rhGH) in the growth hormone (GH) arm of the study.
• Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Fatigue

Interventions

Growth Hormone; Human Growth Hormone; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Randall J Urban, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Melinda Sheffield-Moore, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Brent Masel, MD

  Transitional Learning Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: April 15, 2014
• Study Start: December 12, 2014
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Locations

US (1)