Sildenafil and Stroke Recovery

Recruiting

Phase 1 Results N/A

Trial Description

This is a small, pilot randomized clinical trial of administering sildenafil citrate to individuals within 10 days of ischemic stroke who have motor impairment and who are undergoing inpatient rehabilitation compared to placebo. The primary outcome is motor recovery at one and three months.

Detailed Description

Individuals who are within 4-10 days post ischemic stroke with arm hemiparesis or hemiplegia who are admitted to inpatient rehabilitation are randomized to receive either sildenafil citrate (25 mg once per day) or placebo for 14 days. These individuals receive usual rehabilitation and medical care. Primary outcomes are motor skills and walking speed at one and three months.
If willing and able, participants undergo an MRI to measure the integrity of the white matter pathways in the motor system using diffusion tensor imaging. Repeat MRIs are obtained at one and three months. The investigators will examine if such white matter integrity predicts response to the drug and if the drug facilitates changes in white matter.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: control
    Description: placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
  • Sildenafil citrate Drug
    Other Names: Viagra
    ARM 1: Kind: Experimental
    Label: Drug
    Description: Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Motor Assessment change from baseline at 1 month No
Primary Fugl-Meyer Assessment change from baseline at 3 months No
Secondary 10 meter walk change from baseline at one month No
Secondary Wolf Motor Function Test baseline, one month, three months No
Secondary Motor Activity Log one month No
Secondary Stroke Impact Scale one month No

Sponsors