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StrokePhase 1NCT02628847

Sildenafil and Stroke Recovery

A Phase 1 study testing sildenafil citrate in people with Stroke, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
sildenafil citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
1 siteUnited States
Study dates
Mar 2012to Oct 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • hemorrhagic stroke or subarachnoid hemorrhage;
  • other neurological or psychiatric conditions deemed by the investigator to impair participation;
  • no previous stroke on same side of brain unless that stroke was cerebellar
  • moribound or not expected to live 6 months;
  • contraindications to taking sildenafil in pill or syrup form;
  • 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.
Show all 10Show fewer
  • scores > 50 on the upper extremity section of the Fugl-Meyer or no walking/gait impairment
  • For the MRI portion of the study only:
  • contraindication to MRI: ferrous metal in body, lead included body art, claustrophobia, pacemaker
  • allergic to or had previous reaction to gadolinium

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

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.

Read the 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
Stroke
Being tested
sildenafil citrate, Placebo
Keywords
stroke, rehabilitation, motor skills, sildenafil citrate, White matter
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sildenafil citrateDrug

    Also called Viagra

  • PlaceboDrug

Study groups in NCT02628847
Study groupRoleWhat they receive
DrugExperimentalSildenafil citrate 25mg once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
Receives: Drug: sildenafil citrate
controlPlacebo comparatorplacebo capsule once per day for 14 days starting day 5-9 post stroke while undergoing usual rehabilitation
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Motor Assessment

    An assessment of upper extremity and lower extremity motor impairment

    Measured: change from baseline at 1 month

  2. Fugl-Meyer Assessment

    An assessment of upper extremity and lower extremity motor impairment

    Measured: change from baseline at 3 months

Secondary outcomes (8)

  1. 10 meter walk

    an assessment of usual gait speed

    Measured: change from baseline at one month

  2. Wolf Motor Function Test

    An assessment of motor function

    Measured: baseline, one month, three months

  3. Motor Activity Log

    A self-report of paretic arm (frequency and perceived ability) use in every day activities

    Measured: one month

  4. Stroke Impact Scale

    A self-report measure of the impact of stroke on the individual for body functions, activities, and participation

    Measured: one month

  5. 10 meter walk

    an assessment of usual gait speed

    Measured: change from baseline at 3 months

  6. Wolf Motor Function Test

    An assessment of motor function

    Measured: change from baseline at 3 months

  7. Motor Activity Log

    A self-report of paretic arm (frequency and perceived ability) use in every day

    Measured: 3 months

  8. Stroke Impact Scale

    A self-report measure of the impact of stroke on the individual for body

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2015 (estimated)
  2. Study startMar 2012
  3. Primary completionOct 2016
  4. Study completionOct 2016

Why it stopped: Recruitment was problematic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02628847
Sponsor's protocol ID
53515
Status last verified
Jan 2017
First submitted
7 Dec 2015
Last updated
5 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Zhang RL, Chopp M, Roberts C, Wei M, Wang X, Liu X, Lu M, Zhang ZG. Sildenafil enhances neurogenesis and oligodendrogenesis in ischemic brain of middle-aged mouse. PLoS One. 2012;7(10):e48141. doi: 10.1371/journal.pone.0048141. Epub 2012 Oct 31.

    PubMed 23118941

  • Zhang L, Zhang RL, Wang Y, Zhang C, Zhang ZG, Meng H, Chopp M. Functional recovery in aged and young rats after embolic stroke: treatment with a phosphodiesterase type 5 inhibitor. Stroke. 2005 Apr;36(4):847-52. doi: 10.1161/01.STR.0000158923.19956.73. Epub 2005 Mar 3.

    PubMed 15746452

  • Zhang R, Wang Y, Zhang L, Zhang Z, Tsang W, Lu M, Zhang L, Chopp M. Sildenafil (Viagra) induces neurogenesis and promotes functional recovery after stroke in rats. Stroke. 2002 Nov;33(11):2675-80. doi: 10.1161/01.str.0000034399.95249.59.

    PubMed 12411660

  • Li L, Jiang Q, Zhang L, Ding G, Gang Zhang Z, Li Q, Ewing JR, Lu M, Panda S, Ledbetter KA, Whitton PA, Chopp M. Angiogenesis and improved cerebral blood flow in the ischemic boundary area detected by MRI after administration of sildenafil to rats with embolic stroke. Brain Res. 2007 Feb 9;1132(1):185-92. doi: 10.1016/j.brainres.2006.10.098. Epub 2006 Dec 26.

    PubMed 17188664

  • Ding G, Jiang Q, Li L, Zhang L, Zhang ZG, Ledbetter KA, Gollapalli L, Panda S, Li Q, Ewing JR, Chopp M. Angiogenesis detected after embolic stroke in rat brain using magnetic resonance T2*WI. Stroke. 2008 May;39(5):1563-8. doi: 10.1161/STROKEAHA.107.502146. Epub 2008 Mar 20.

    PubMed 18356548

  • Ding G, Jiang Q, Li L, Zhang L, Zhang ZG, Ledbetter KA, Panda S, Davarani SP, Athiraman H, Li Q, Ewing JR, Chopp M. Magnetic resonance imaging investigation of axonal remodeling and angiogenesis after embolic stroke in sildenafil-treated rats. J Cereb Blood Flow Metab. 2008 Aug;28(8):1440-8. doi: 10.1038/jcbfm.2008.33. Epub 2008 Apr 16.

    PubMed 18418368

  • Ding G, Jiang Q, Li L, Zhang L, Zhang Z, Lu M, Li Q, Gu S, Ewing J, Chopp M. Longitudinal magnetic resonance imaging of sildenafil treatment of embolic stroke in aged rats. Stroke. 2011 Dec;42(12):3537-41. doi: 10.1161/STROKEAHA.111.622092. Epub 2011 Sep 8.

    PubMed 21903952

  • Silver B, McCarthy S, Lu M, Mitsias P, Russman AN, Katramados A, Morris DC, Lewandowski CA, Chopp M. Sildenafil treatment of subacute ischemic stroke: a safety study at 25-mg daily for 2 weeks. J Stroke Cerebrovasc Dis. 2009 Sep-Oct;18(5):381-3. doi: 10.1016/j.jstrokecerebrovasdis.2009.01.007.

    PubMed 19717023

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sildenafil citrate in people with Stroke, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment was problematic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Motor Assessment (time frame: change from baseline at 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02628847, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.

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Sildenafil and Stroke Recovery (NCT02628847) | AzTrials