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Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity

NCT00945295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-11-01

Study results available
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Summary

The purpose of this study is to determine if a combination of botulinum neurotoxin A and rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in function based on the Fugl-Meyer and other validated measures.

Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.

Conditions

  • Upper Limb Spasticity

Interventions

DRUG

Botulinum toxin type A, BoNT-A

Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

OTHER

Rehabilitation Therapy

Rehabilitation therapy

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • JoAnn Harnar

    lead OTHER

Principal Investigators

  • Glenn D. Graham, MD, PhD · New Mexico VA Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

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 NCT00945295 on ClinicalTrials.gov