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Sildenafil and Stroke Recovery

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ClinicalTrials.gov Identifier: NCT02628847
Recruitment Status : Terminated (Recruitment was problematic)
First Posted : December 11, 2015
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Lorie Richards, 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.

Condition or disease Intervention/treatment Phase
Stroke Drug: sildenafil citrate Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sildenafil and Stroke Recovery
Study Start Date : March 2012
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug
Sildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
Drug: sildenafil citrate
Other Name: Viagra

Placebo Comparator: control
placebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
Drug: Placebo



Primary Outcome Measures :
  1. Fugl-Meyer Motor Assessment [ Time Frame: change from baseline at 1 month ]
    An assessment of upper extremity and lower extremity motor impairment

  2. Fugl-Meyer Assessment [ Time Frame: change from baseline at 3 months ]
    An assessment of upper extremity and lower extremity motor impairment


Secondary Outcome Measures :
  1. 10 meter walk [ Time Frame: change from baseline at one month ]
    an assessment of usual gait speed

  2. Wolf Motor Function Test [ Time Frame: baseline, one month, three months ]
    An assessment of motor function

  3. Motor Activity Log [ Time Frame: one month ]
    A self-report of paretic arm (frequency and perceived ability) use in every day activities

  4. Stroke Impact Scale [ Time Frame: one month ]
    A self-report measure of the impact of stroke on the individual for body functions, activities, and participation

  5. 10 meter walk [ Time Frame: change from baseline at 3 months ]
    an assessment of usual gait speed

  6. Wolf Motor Function Test [ Time Frame: change from baseline at 3 months ]
    An assessment of motor function

  7. Motor Activity Log [ Time Frame: 3 months ]
    A self-report of paretic arm (frequency and perceived ability) use in every day

  8. Stroke Impact Scale [ Time Frame: 3 months ]
    A self-report measure of the impact of stroke on the individual for body


Other Outcome Measures:
  1. Number of participants with unsafe Blood pressure change [ Time Frame: one month ]
    blood pressure reductions or increases while taking the drug/placebo

  2. number of participants with cardiovascular side effects [ Time Frame: one month ]
    cardiovascular events, such as heart attack, angina pectoris, heart failure

  3. number of participants with visual side effects [ Time Frame: one month ]
    new abnormal color vision, light sensitivity, blurred vision or other visual side effects

  4. number of participants with auditory or vestibular side effects [ Time Frame: one month ]
    new loss of hearing, tinnitus, dizziness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628847


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Lorie G Richards, PhD University of Utah

Publications of Results:

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Responsible Party: Lorie Richards, Chair and Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02628847    
Other Study ID Numbers: 53515
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lorie Richards, University of Utah:
stroke
rehabilitation
motor skills
sildenafil citrate
White matter
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Sildenafil Citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents