Sildenafil and Stroke Recovery

Phase 1

Terminated

• Conditions: Stroke
• Interventions: Drug: sildenafil citrate; Drug: Placebo

• Registration Number: NCT02628847
• Lead Sponsor: University of Utah

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug	sildenafil citrate	Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
control	Placebo	placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Motor Assessment	change from baseline at 1 month	An assessment of upper extremity and lower extremity motor impairment
Fugl-Meyer Assessment	change from baseline at 3 months	An assessment of upper extremity and lower extremity motor impairment

Secondary Outcome Measures

Name	Time	Method
10 meter walk	change from baseline at 3 months	an assessment of usual gait speed
Wolf Motor Function Test	change from baseline at 3 months	An assessment of motor function
Motor Activity Log	3 months	A self-report of paretic arm (frequency and perceived ability) use in every day
Stroke Impact Scale	3 months	A self-report measure of the impact of stroke on the individual for body

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States