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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

Study Summary

This trial will investigate whether a PDE5 inhibitor can augment cerebrovascular reactivity in patients with a history of repetitive mild traumatic brain injury.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of single dose sildenafil citrate treatment on global blood oxygen level-dependent (BOLD) response to hypercapnia.
Secondary outcome measures
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 outcome measures
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%
Vertigo
10%
Bronchitis
10%
Flushing
10%
Palpitations
10%
Nasopharyngitis
8%
Respiratory tract infection
6%
Pulmonary hypertension
6%
Depression
6%
Presyncope
6%
Dyspnoea
6%
Right ventricular failure
6%
Vision blurred
4%
Pulmonary arterial hypertension
4%
Upper respiratory tract infection
4%
Bronchopneumonia
4%
Anaemia
2%
Hypertension
2%
Cough
2%
Acute coronary syndrome
2%
Inguinal hernia
2%
Asthenia
2%
Cardiovascular disorder
2%
Mitral valve incompetence
2%
Gangrene
2%
Respiratory syncytial virus infection
2%
Urinary tract infection
2%
Walking distance test abnormal
2%
Breast cancer
2%
Uterine haemorrhage
2%
Haemoptysis
2%
Hypoxia
2%
Skin ulcer
2%
Nausea
2%
Back pain
2%
Death
2%
General physical health deterioration
2%
Circulatory collapse
2%
Cardiac failure
2%
Coronary artery disease
2%
Chest discomfort
2%
Pancreatic neoplasm
2%
Haemoglobin decreased
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sildenafil

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
2,002 Previous Clinical Trials
42,880,992 Total Patients Enrolled
Boston UniversityOTHER
454 Previous Clinical Trials
9,941,563 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Cerebrovascular Reactivity in American Football Players
Ramon Diaz-Arrastia 2018. "Cerebrovascular Reactivity in American Football Players". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03417492.
~1 spots leftby Apr 2025
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