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NCT02114775
Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)
Phase 1 trial testing Growth Hormone in Traumatic Brain Injury in 34 participants. Completed in 10 November 2017.
10 November 2017
Quick facts
| Lead sponsor | The University of Texas Medical Branch, Galveston |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 34 |
| Start date | 12 December 2014 |
| Primary completion | 10 November 2017 |
| Estimated completion | 10 November 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Growth Hormone — full drug profile →
- Sildenafil (sildenafil) — full drug profile →
- Placebo
Conditions studied
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
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):
-
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 -
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:
- PubMed search for NCT02114775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT04532554 — Growth Hormone in Obese Cases With Covid-19 · Phase 4 · withdrawn
Other recruiting trials for Traumatic Brain Injury
Currently open trials in the same condition.
- NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
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- NCT07455136 — A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Mon · recruiting
- NCT07404761 — Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments · NA · recruiting
- NCT07230002 — Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in N · NA · recruiting
Other The University of Texas Medical Branch, Galveston trials
Trials by the same sponsor.
- NCT04095260 — Identification of Neuromusculoskeletal Variables Associated With Injury Risk and Performance in High School Athletes. · not yet recruiting
- NCT06800092 — Sildenafil to Prevent and Reduce Cancer Related Cognitive Impairment · Phase 2, PHASE3 · not yet recruiting
- NCT07337915 — Improving Sleep In Midlife Women · NA · recruiting
- NCT07203287 — Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease · Phase 4 · recruiting
- NCT07087743 — Virtual Reality-Integrated Propulsion Feedback for Stroke Rehab · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02114775 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston
- Last refreshed: 5 February 2018
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