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Phosphodiesterase 5 Inhibitor

Sildenafil Citrate for Post-Concussion Syndrome

Phase 1
Waitlist Available
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 immediate
Awards & highlights
No Placebo-Only Group

Summary

This trial involves giving sildenafil citrate (Viagra) to patients with repetitive mild traumatic brain injury to improve their brain blood flow. The drug works by relaxing blood vessels, which may help these patients recover better.

Eligible Conditions
  • Post-Concussion Syndrome
  • Traumatic Brain Injury
  • Concussion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.
Secondary study objectives
Effect of single dose sildenafil citrate treatment on functional near-infrared spectroscopy (fNIRS) response to hypercapnia.
Maximum tolerable dose of sildenafil therapy without severe adverse events.
Other study objectives
Effect of 5 weeks of sildenafil treatment on attention using Trail Making Test Part A.
Effect of 5 weeks of sildenafil treatment on attention using the Digit Symbol Modalities Test.
Effect of 5 weeks of sildenafil treatment on daily function using the Functional Activities Questionnaire.
+7 more

Side effects data

From 2013 Phase 4 trial • 105 Patients • NCT00323297
14%
Diarrhoea
14%
Oedema peripheral
14%
Headache
10%
Flushing
10%
Bronchitis
10%
Nasopharyngitis
10%
Vertigo
10%
Palpitations
8%
Respiratory tract infection
6%
Depression
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
6%
Presyncope
6%
Pulmonary hypertension
4%
Anaemia
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
2%
Nausea
2%
Cardiac failure
2%
Cough
2%
Acute coronary syndrome
2%
Hypoxia
2%
Cardiovascular disorder
2%
Haemoglobin decreased
2%
Death
2%
Skin ulcer
2%
Back pain
2%
Haemoptysis
2%
Chest discomfort
2%
Walking distance test abnormal
2%
Coronary artery disease
2%
Pancreatic neoplasm
2%
Breast cancer
2%
Uterine haemorrhage
2%
Mitral valve incompetence
2%
Inguinal hernia
2%
Circulatory collapse
2%
General physical health deterioration
2%
Urinary tract infection
2%
Asthenia
2%
Respiratory syncytial virus infection
2%
Gangrene
2%
Sinusitis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sildenafil CitrateExperimental Treatment1 Intervention
Open label treatment with forced titration of sildenafil citrate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil Citrate
2021
Completed Phase 4
~1590

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,076 Previous Clinical Trials
42,719,818 Total Patients Enrolled
Boston UniversityOTHER
472 Previous Clinical Trials
9,987,819 Total Patients Enrolled
~1 spots leftby Nov 2025
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