NCT00452582

Brief Summary

Stroke is the third leading cause of death in the United States and the leading cause of serious long-term disability. Approximately 50% of the 750,000 people affected by stroke each year have residual physical impairment. Treatment options for recovery are limited at this time. Sildenafil (Viagra) has demonstrated the capability of significantly improving recovery in several animal experiments of stroke. This study is aiming to establish the safety of treatment with sildenafil in people with stroke with the ultimate aim of testing its usefulness to improve recovery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

First QC Date

March 26, 2007

Last Update Submit

March 15, 2011

Conditions

Ischemic Stroke

Keywords

ischemic strokerecoverysildenafil

Outcome Measures

Primary Outcomes (1)

  • The maximum tolerated dose and toxicity profile of sildenafil treatment in patients with subacute ischemic stroke.

    2 weeks

Secondary Outcomes (1)

  • The estimated efficacy of sildenafil in comparison with concurrent patients randomized assigned to usual care.

    3 months

Study Arms (2)

Sildenafil

EXPERIMENTAL

Orally administered sildenafil in addition to usual care.

Drug: Sildenafil (Viagra)

Usual post-stroke care

ACTIVE COMPARATOR

Usual post-stroke treatment including physical, occupational, and speech therapy.

Other: Usual care

Interventions

Sildenafil (Viagra)DRUG

Dose escalation (one of the following): 25 mg daily for 2 weeks, 50 mg daily for 2 weeks, 75 mg daily for 2 weeks, 50 mg twice daily for two weeks, 50 mg AM and 75 mg PM for 2 weeks, 75 mg twice daily for 2 weeks, 75 mg in AM and 100 mg in PM for 2 weeks, 100 mg twice daily for 2 weeks.

Sildenafil
Usual careOTHER

Physical therapy, occupational therapy, speech therapy

Usual post-stroke care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ischemic stroke between 4 and 7 days after symptom onset.
  • Patients age 18-80 years old.
  • NIHSS score of 5-21 prior to treatment (within each cohort, there will be no more than 4 patients with NIHSS \< 9 and no fewer than 4 patients with NIHSS \> 11).
  • Signed IRB-approved informed consent by patient or authorized representative.

You may not qualify if:

  • General:
  • Participation in another study with an investigational drug or device.
  • Women known to be pregnant, lactating, or of childbearing potential with a positive urine beta-HCG.
  • Patients who cannot receive oral medications.
  • Patients using sildenafil or other phosphodiesterase inhibitors within the previous 7 days of stroke.
  • Safety Related:
  • Unstable angina.
  • Myocardial infarction within 3 months.
  • Current use of nitrate agents.
  • Current use of alpha-channel antagonists.
  • Current use of medications that inhibit the cytochrome p450 3A4 system. These medications include: amiodarone, aprepitant, bosentan, cimetidine, cisapride, clarithromycin, delavirdine, diltiazem, efavirenz, erythromycin, fluconazole, fluvoxamine, grapefruit juice, imatinib, itraconazole, ketoconazole,loratadine, mibefradil, mifepristone (RU-486), niacin, nefazodone, quinidine, quinine, ritonavir, saquinavir, tacrolimus, verapamil, voriconazole.
  • St. John's Wort and phenytoin (inducers of cytochrome P450 3A4)
  • Baseline systolic blood pressure less than 100 mmHg.
  • Penile deformities.
  • Creatinine \> 1.5.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • 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: 19717023RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Brian Silver, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 27, 2007

Study Start

April 1, 2005

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

US(1)