Sildenafil and Stroke Recovery

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 1

Conditions: Stroke

Treatments: Drug: sildenafil citrate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02628847

53515

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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11 participants in 2 patient groups, including a placebo group

Drug

Experimental group

Description:

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

Treatment:

Drug: sildenafil citrate

control

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo