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Sildenafil for Traumatic Brain Injury (CVR-TBI Trial)

Phase 2
Recruiting
Led By Ramon Diaz-Arrastia, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed over 4 week daily intervention of 3 doses of sildenafil in tbi patients

Summary

"This trial aims to study the effects of sildenafil, a drug approved for erectile dysfunction and pulmonary hypertension, on traumatic brain injury (TBI) patients. Previous studies have shown that sildenafil may improve blood flow

Who is the study for?
This trial is for men and women aged 18-55 who have had a traumatic brain injury (TBI) with symptoms lasting long after the injury. They must be able to consent, follow study rules, and have TBI evidence on a CT or MRI scan or through specific identification methods. Participants should also have ongoing post-concussion symptoms and a moderate level of recovery.
What is being tested?
The trial tests different doses of Sildenafil (20 mg, 40 mg, 80 mg) to see if they can improve blood flow in the brain's tiny vessels in chronic TBI patients. It compares these doses against a placebo over four weeks to check which dose might work best for improving microvascular function.
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, vision changes like blurred vision or blue-tinted sight. These side effects are generally mild but can vary based on the dosage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Optimal Dose
Secondary study objectives
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Other study objectives
Clinician Interview-Based Impression (CIBI)
Glasgow Outcome Scale-Extended (GOSE)
Headache Impact Test-6 (HIT-6)
+3 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Sildenafil citrate low doseActive Control1 Intervention
Sildenafil citrate 20 mg, oral, TID
Group II: Sildenafil citrate medium doseActive Control1 Intervention
Sildenafil citrate 40 mg, oral, TID
Group III: Sildenafil citrate high doseActive Control1 Intervention
Sildenafil citrate 80 mg, oral, TID
Group IV: PlaceboPlacebo Group1 Intervention
Placebo, oral, TID

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,888 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
143 Previous Clinical Trials
33,244 Total Patients Enrolled
Ramon Diaz-Arrastia, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania
11 Previous Clinical Trials
5,986 Total Patients Enrolled
~107 spots leftby Dec 2027
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