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Sildenafil citrate low dose for Traumatic Brain Injury

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 between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed over 4 week daily intervention of 3 doses of sildenafil in tbi patients

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline visit

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Optimal Dose

Secondary outcome measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Other outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,009 Previous Clinical Trials

42,894,493 Total Patients Enrolled

Walter Reed National Military Medical CenterFED

138 Previous Clinical Trials

33,378 Total Patients Enrolled

Ramon Diaz-Arrastia, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania

11 Previous Clinical Trials

5,986 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who have not yet reached the age of 18 eligible to participate in this study?

"Participants meeting the study criteria must be over 18 years old but under 55 years old."

Answered by AI

What is the safety profile of a low dose of Sildenafil citrate in individuals?

"In this Phase 2 trial, the safety of low-dose Sildenafil citrate is assessed at a level of 2 by our team at Power. This indicates that there is preliminary data supporting its safety but not yet for efficacy."

Answered by AI

Is the enrollment for participants currently open in this clinical trial?

"Affirmative. The details available on clinicaltrials.gov indicate an ongoing patient recruitment for this specific clinical trial. Originally posted on April 1, 2024, and last updated on April 16, 2024, the trial aims to enroll a total of 160 participants at one specified site."

Answered by AI

What is the current number of individuals participating in this research project?

"Indeed, the details on clinicaltrials.gov indicate an active pursuit of suitable participants for this medical investigation. The trial was initially disclosed on April 1st, 2024 and last revised on April 16th, 2024. A total of 160 patients are sought after at a single research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sildenafil for Microvasculopathy in Chronic TBI

2024. "Sildenafil for Microvasculopathy in Chronic TBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05782244.

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