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New treatment option for Traumatic Brain Injury
Official title Sildenafil for Microvasculopathy in Chronic TBI
ClinicalTrials.gov ID: NCT05782244
What this study is testing
What is Sildenafil Citrate low dose?
Sildenafil Citrate low dose is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for traumatic brain injury.
Also referred to as Sildenafil lowest dose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-70
- Defense Enrollment Eligibility Reporting System (DEERS) eligible (WRNMMC only; N/A for UPenn)
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Contraindication to sildenafil which includes the following:
- Current/ongoing (within past month) use of organic nitrate vasodilators or riociguat
- Current/ongoing (within past month) use of ritonavir (HIV-protease inhibitor)
- Current/ongoing (within past month) use of erythromycin, ketoconazole, or itraconazole
- Current/ongoing (within past month) use of cimetidine
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-70
- Defense Enrollment Eligibility Reporting System (DEERS) eligible (WRNMMC only; N/A for UPenn)
- History of TBI greater than 6 months and less than 25 years prior to enrollment, based on the 2023 American Congress of Rehabilitation Medicine Criteria92;
- Plausible Mechanism of Injury: Criterion 1 focuses on the external force that likely disrupted brain function, including blast/explosion forces and acknowledging intentional causes.
- Clinical Signs: Criterion 2 highlights signs observed or elicited during examination, distinguishing them from subjective symptoms.
- Acute Symptoms: Criterion 3 considers subjective acute symptoms, requiring at least two symptoms to be present.
- Clinical Examination/Laboratory Findings: Criterion 4 is a new addition, incorporating findings like cognitive impairment or oculomotor impairment.
- Neuroimaging: While not required for diagnosis, neuroimaging can be used to provide further evidence of brain injury.
- Chronic persistent post-concussive symptoms (Symptom Score \> 1 on at least 3 items from the Rivermead Post-Concussion Symptom Questionnaire; RPQ)
- Glasgow Outcome Scale-Extended (GOSE) between 5-7
- Ability to take oral medication and be willing to adhere to the study intervention regimen
- Ability to participate in and complete 1 MRI including 2 CVR challenges and 4-week treatment period.
- Adequate hearing and vision based on self-report and examiner's observation
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Contraindication to sildenafil which includes the following:
- Current/ongoing (within past month) use of organic nitrate vasodilators or riociguat
- Current/ongoing (within past month) use of ritonavir (HIV-protease inhibitor)
- Current/ongoing (within past month) use of erythromycin, ketoconazole, or itraconazole
- Current/ongoing (within past month) use of cimetidine
- Current resting hypotension (BP \< 90/50 mm Hg)
- Current severe renal insufficiency
- Current hepatic cirrhosis
- Current cardiac failure or coronary artery disease causing unstable angina
- Retinitis pigmentosa
- Known hypersensitivity or allergy to sildenafil of any of its components
- History of melanoma or suspicious skin lesions for melanoma on skin examination
- Daily therapy with a PDE5 inhibitor within the month prior to consent
- History of penetrating TBI
- History of disabling neurological or psychiatric disorder not related to TBI
- Active substance abuse or dependence during the past 6 months
- Estimated preinjury intellectual level ≤70 (based on educational and vocational history)
- Inability to understand written and spoken English, in the opinion of the investigator
- Current inclusion in another treatment trial
- people with metal implants that would interfere with the MR imaging procedures
- History of priapism
- Pregnant or breast-feeding women
- Actively suicidal (based on clinician assessment OR if patient endorses item 9 on Patient Health Questionnaire 9 (PHQ-9) and endorses suicidal ideation on Columbia Suicide Severity Rating Scale(CSSRS)
- Hypertension requiring treatment with more than two antihypertensive drugs
- Hyperlipidemia requiring treatment with more than one lipid lowering drug
- Diabetes mellitus requiring medical treatment with insulin
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.