Sildenafil and Stroke Recovery

NCT02628847 | Terminated Phase 1

• 1 other identifier: 53515
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; motor skills; sildenafil citrate; White matter

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Motor Assessment

  An assessment of upper extremity and lower extremity motor impairment

  change from baseline at 1 month

• Fugl-Meyer Assessment

  An assessment of upper extremity and lower extremity motor impairment

  change from baseline at 3 months

Secondary Outcomes (8)

• 10 meter walk

  change from baseline at one month

• Wolf Motor Function Test

  baseline, one month, three months

• Motor Activity Log

  one month

• Stroke Impact Scale

  one month

• 10 meter walk

  change from baseline at 3 months

Other Outcomes (4)

• Number of participants with unsafe Blood pressure change

  one month

• number of participants with cardiovascular side effects

  one month

• number of participants with visual side effects

  one month

Study Arms (2)

Drug

EXPERIMENTAL

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

Drug: sildenafil citrate

control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

sildenafil citrate DRUG

Also known as: Viagra

Drug

Placebo DRUG

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (8)

• 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.

  PMID: 23118941 RESULT

• 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.

  PMID: 15746452 RESULT

• 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.

  PMID: 12411660 RESULT

• 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.

  PMID: 17188664 RESULT

• 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.

  PMID: 18356548 RESULT

• 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.

  PMID: 18418368 RESULT

• 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.

  PMID: 21903952 RESULT

• 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.

  PMID: 19717023 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lorie G Richards, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Associate Professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 11, 2015
• Study Start: March 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

US (1)