Last reviewed · How we verify

NCT02114775

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

Completed Phase 1 Last updated 5 February 2018
What this trial tests

Phase 1 trial testing Growth Hormone in Traumatic Brain Injury in 34 participants. Completed in 10 November 2017.

Timeline
12 December 2014
Primary endpoint
10 November 2017
10 November 2017

Quick facts

Lead sponsorThe University of Texas Medical Branch, Galveston
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposediagnostic
Enrollment34
Start date12 December 2014
Primary completion10 November 2017
Estimated completion10 November 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 18 to 60, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Growth Hormone Alters Brain Morphometry, Connectivity, and Behavior in Subjects with Fatigue after Mild Traumatic Brain Injury.
    Wright T, Urban R, Durham W, Dillon EL, et al · · 2020 · cited 27× · PMID 31797721 · DOI 10.1089/neu.2019.6690
  2. Sildenafil-Mediated Neuroprotection from Adult to Neonatal Brain Injury: Evidence, Mechanisms, and Future Translation.
    Zinni M, Pansiot J, Léger PL, El Kamouh M, et al · · 2021 · cited 15× · PMID 34685745 · DOI 10.3390/cells10102766

Verify or expand the search:

Other trials of Growth Hormone

Trials testing the same drug.

Other recruiting trials for Traumatic Brain Injury

Currently open trials in the same condition.

Other The University of Texas Medical Branch, Galveston trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02114775.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing