Sildenafil and Stroke Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug

Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation

Group Type EXPERIMENTAL

sildenafil citrate

Intervention Type DRUG

control

placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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sildenafil citrate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Viagra

Eligibility Criteria

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Inclusion Criteria

1. between 4 and 9 days post-ischemic stroke;
2. admitted to inpatient rehabilitation;
3. cognitively able to provide consent or assent;
4. were living independently in the community prior to their stroke.

Exclusion Criteria

1. hemorrhagic stroke or subarachnoid hemorrhage;
2. other neurological or psychiatric conditions deemed by the investigator to impair participation;
3. no previous stroke on same side of brain unless that stroke was cerebellar
4. moribound or not expected to live 6 months;
5. contraindications to taking sildenafil in pill or syrup form;
6. other medical conditions that would limit ability to participate in the study, specifically a) currently taking the P450 enzyme inhibitors (erythromycin, ketoconazole, itraconazole, saquinavir), b) currently taking the protease inhibitor ritonavir, c) currently taking nitrates or have a history of requiring nitrates treatment, d) have left ventricular outflow obstruction (i.e., aortic stenosis, idiopathic hypertrophic subaortic stenosis as confirmed by review of standard of care echo received before admission to rehabilitation), e) have severely impaired autonomic control of blood pressure, f) have previous history of symptomatic hypotension, g) have severely impaired hepatic function, h) is pregnant or become pregnant during the course of the study, i) Any medical condition which, in the opinion of the investigator, may compromise compliance with the objectives and/or procedures of the protocol.
7. scores \> 50 on the upper extremity section of the Fugl-Meyer or no walking/gait impairment

For the MRI portion of the study only:
8. contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker
9. allergic to or had previous reaction to gadolinium

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No