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NCT05782244 · ClinicalTrials.gov registry record · Phase 2
Sildenafil for Microvasculopathy in Chronic TBI
A Phase 2 study of Traumatic Brain Injury, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT05782244 is a Phase 2 study of Traumatic Brain Injury that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 160 participants, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05782244, a Phase 2 study of Traumatic Brain Injury, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ameliorate the consequences of TBI. Sildenafil potentiates nitric oxide (NO) dependent vasodilatation and is approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction and primary pulmonary hypertension. In pre-clinical models of stroke, sildenafil improves cerebral blood flow (CBF), promotes, angiogenesis, neurogenesis and improves recovery. In an initial Phase 2a trial (NCT01762475) of sildenafil in patients with chronic moderate to severe TBI, the investigators found that low dose sildenafil (25 mg BID) therapy is safe and well tolerated, that a single dose of sildenafil 50 mg potentiates CVR in areas of the brain with dysfunctional endothelium, and that CVR is a reliable diagnostic marker of TCVI and has potential as a pharmacodynamic and predictive biomarker. In this proposal, the investigators will conduct a randomized clinical trial to determine the optimal PDE5 inhibitor dose to improve or normalize microvascular function (as measured by the change in CVR measurements before and after a single dose of sildenafil, or ΔCVR) using a range of sildenafil citrate doses: 20, 40, 80 mg) in chronic TBI patients. The investigators will also test the safety and tolerability of the same dose ranges of chronic (4-week) thrice daily sildenafil or placebo administration in chronic TBI patients and explore its effects on chronic symptoms and clinical outcomes.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sildenafil Citrate low dose
- DRUG Sildenafil medium dose
- DRUG Sildenafil high dose
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05782244
The ClinicalTrials.gov registry entry for NCT05782244 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (42% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05782244 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05782244 about?
NCT05782244 is a clinical study titled "Sildenafil for Microvasculopathy in Chronic TBI". Traumatic Cerebral Vascular Injury (TCVI) is a common consequence of traumatic brain injury (TBI), including mild TBI (mTBI). TCVI is associated with poor recovery after TBI in animal models. TCVI can be measured non-invasively in humans, and therapies targeting TCVI are attractive candidates to ame...
What is the current status of trial NCT05782244?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2024-07-02. Estimated completion is 2027-12-31.
What conditions does trial NCT05782244 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT05782244?
The interventions under investigation include: Placebo (DRUG), Sildenafil Citrate low dose (DRUG), Sildenafil medium dose (DRUG), Sildenafil high dose (DRUG).
Who is sponsoring clinical trial NCT05782244?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05782244 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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