Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purposes of this pilot study are to evaluate the safety and efficacy of Botox® compared to the safety and efficacy of oral baclofen in reducing muscle tone-related disability resulting from neurological damage or a stable neurological disorder and to evaluate drug-therapy tolerance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Outpatient, male or female subjects of any race, and at least 18 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 50mlU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study;

• Minimal 4-month history stable neurological disorder resulting focal upper limb muscle spasticity (wrist and/or elbow)

• Disability Assessment Scale (DAS) ≥ 2 for the principal therapeutic intervention target as chosen by Investigator and Subject (i.e., hygiene, dressing, pain and cosmesis).

• Subjects who are able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms.

Locations
United States
Tennessee
Vanderbilt University
Nashville
Time Frame
Start Date: February 2006
Completion Date: February 2009
Participants
Target number of participants: 8
Treatments
Experimental: 1
This study will explore the safety and effectiveness of Botox versus baclofen in treatment subjects with upper-limb spasticity due to neurological damage or a stable neurological disorder. Subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo or intramuscular placebo plus oral baclofen.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University

This content was sourced from clinicaltrials.gov

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