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SISTERS: Spasticity In Stroke Study - Randomized Study

NCT01032239 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-02-15

Study results available
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Summary

To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.

Conditions

  • Severe Spasticity

Interventions

DRUG

intrathecal baclofen

ITB test, implant, 6 months follow-up

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Leopold SALTUARI, Prof. · Landeskrankenhaus Hochzirl, Zirl (Austria)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States
  • Austria
  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Slovenia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01032239 on ClinicalTrials.gov