Table 2.
Ongoing or completed clinical trials testing sildenafil to prevent brain injury.
| NCT/Status/Study Title | Condition | Comparator | Phase | Primary Outcome | Main Effect | Comment/Reference |
|---|---|---|---|---|---|---|
|
NCT02628847 (Terminated) Sildenafil and Stroke Recovery |
Adult stroke | Placebo | 1 | Motor recovery at one and three months | Unknown | Recruitment was problematic |
|
NCT00452582 (Terminated) Sildenafil (Viagra) Treatment of Subacute Ischemic Stroke |
Adult ischemic stroke | Usual care | 1 | The maximum tolerated dose and toxicity profile of sildenafil treatment in patients with subacute ischemic stroke | Sildenafil appeared to be safe in patients with mild to moderately severe stroke | Failure to recruit in expected time period |
|
NCT03855332 (Recruiting) Oxford Haemodynamic Adaptation to Reduce Pulsatility Trial (OxHARP) |
Small vessel cerebrovascular disease in adult | Cilostazol Placebo |
2 | Middle cerebral arterial pulsatility index | - | Estimated study completion date: December 2022 |
|
NCT01762475 (Completed) Sildenafil for Cerebro-vascular Dysfunction in Chronic Traumatic Brain Injury |
Traumatic brain injury in adults | - | 2 | Cerebrovascular reactivity | Single-dose sildenafil improves regional CVR deficits in chronic TBI patients | [116] |
|
NCT02114775 (Completed) Growth Hormone or Sildenafil as Therapies for Fatigue in Mild-Traumatic-brain-injury (MTBI) |
Traumatic brain injury in adults | Genotropin Placebo |
1 | Performance fatigue | Unknown | Sildenafil was found to increase protein synthesis and reduces muscle fatigue in healthy men |
|
NCT04058132 (Recruiting) Cerebrovascular Reactivity Assessed With fNIRS as a Biomarker of TCVI After Acute Traumatic Brain Injury in Military |
Acute/subacute traumatic brain injury in adults | None | 2 | Variation of oxyhemoglobin and deoxyhemoglobin concentration Longitudinal measure of CVR |
- | Estimated study completion date: April 2021 |
|
NCT02990078 (Recruiting) Non-invasive Measurement of Cerebrovascular Reactivity After Traumatic Brain Injury |
Traumatic brain injury in adults | None | 1 | Change in CVR | - | Estimated study completion date: December 2026 |
|
NCT03417492 (Recruiting) Cerebrovascular Reactivity in American Football Players |
Traumatic brain injury in adults | None | 1 | Effect of single dose sildenafil citrate on global BOLD response to hypercapnia | - | Estimated study completion date: September 2022 |
|
NCT02812433 (Active) Sildenafil Administration to Treat Neonatal Encephalopathy |
Hypoxic ischemic encephalopathy in neonates | Ora-Blend | 1 | Serious adverse events | - | Estimated study completion date: June 2022 |