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NCT03598140
Sildenafil Treatment for Mild TBI
Phase 2 trial testing Sildenafil Citrate in Vascular System Injuries in 22 participants. Terminated before completion.
29 May 2019
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 25 July 2018 |
| Primary completion | 29 May 2019 |
| Estimated completion | 29 May 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sildenafil Citrate (Sildenafil Citrate) — full drug profile →
- Placebo oral capsule
Conditions studied
- Vascular System Injuries — all drugs for Vascular System Injuries →
- Concussion, Brain — all drugs for Concussion, Brain →
- Post-Concussion Syndrome — all drugs for Post-Concussion Syndrome →
Sponsor
University of Texas Southwestern Medical Center
Who can join
Adults 18 to 35, male only, with Vascular System Injuries or Concussion, Brain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
About 300,000 people are hospitalized for traumatic brain injury (TBI) each year. After TBI, secondary brain injury escalates due in part to heightened levels of oxidant injury, inflammation, and vascular injury. Traumatic cerebral vascular injury (TCVI) may begin almost immediately after the primary injury and evolve into chronic neurodegenerative conditions. TCVI is a very complex TBI endophenotype and microvascular injuries have been described in a plethora of animal and human TBI studies. These injuries consist of endothelial injury, disruption of the blood brain barrier (BBB), a reduction of capillary density, intravascular microthrombi, and white-matter degeneration. Recently, use of magnetic resonance imaging (MRI)-Blood Oxygen Level Dependent (BOLD) combined with hypercapnia (high spatial and temporal resolution) by our research group has proven to be more sensitive at measuring alterations of cerebral blood flow (CBF) in TBI subjects. The goal of the proposed research is to test the efficacy of Viagra® (sildenafil) at normalizing CBF and improving cognitive outcomes in people that have experienced a TBI. Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor that has previously been administered as a therapy for high blood pressure and erectile dysfunction. In people that have been affected by stroke-induce neurotrauma, sildenafil improved CBF and was found to be neuroprotective. With respect to chronic TBI, previous studies have demonstrated that sildenafil therapy potentiates cardiovascular reactivity (CVR) in areas of the brain with damaged endothelium. In this proposal, the investigators will test the hypothesis that sildenafil treatment in boxers/Mixed Martial Arts (MMA) fighters soon after concussion normalizes CBF, potentiates CVR, reduces post-concussion symptoms, and improves cognition.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03598140
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04565925 — Sildenafil for Treatment of Urinary Incontinence in Patients With Spinal Cord Injuries · Phase 2 · recruiting
Other recruiting trials for Vascular System Injuries
Currently open trials in the same condition.
- NCT04937868 — Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients · recruiting
Other University of Texas Southwestern Medical Center trials
Trials by the same sponsor.
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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 NCT03598140 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
- Last refreshed: 19 November 2020
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/NCT03598140.
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