Botox vs. Baclofen for Upper Limb Spasticity

• ClinicalTrials.gov Identifier: NCT00280280
• Recruitment Status: Terminated
• First Posted: January 20, 2006
• Last Update Posted: January 20, 2012
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): David Charles, Vanderbilt University

Tracking Information

• First Submitted Date: January 18, 2006
• First Posted Date: January 20, 2006
• Last Update Posted Date: January 20, 2012
• Study Start Date: February 2006
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 13, 2008): Disability Assessment Scale (DAS) [ Time Frame: 4 months ]
• Original Primary Outcome Measures (submitted: January 18, 2006): Disability Assessment Scale (DAS)

Current Secondary Outcome Measures (submitted: May 13, 2008)

• Modified Ashworth Tone [ Time Frame: 4 months ]
• Subject Questionnaires [ Time Frame: 4 months ]
• Contralateral Finger Tap Test [ Time Frame: 4 months ]
• Contralateral Grip Strength [ Time Frame: 4 months ]

Original Secondary Outcome Measures (submitted: January 18, 2006)

• Modified Ashworth Tone
• Subject Questionnaires
• Contralateral Finger Tap Test
• Contralateral Grip Strength

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Botox vs. Baclofen for Upper Limb Spasticity
• Official Title: Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study
• Brief 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.

Detailed Description

Spasticity results from any injury to the central nervous system, including brain or spinal cord. Illnesses or injuries that typically cause spasticity include cerebral palsy, stroke, multiple sclerosis and traumatic brain or spinal cord injury. Common treatments for spasticity include physical and occupational therapy as well as oral medications such as baclofen, injected medications such as botulinum neurotoxin, intrathecal medications and surgical procedures. The approach to the treatment of spasticity is comprehensive in nature and these therapies have been widely applied to a broad population of patients including children, adults and older adults.

This is a single-center, randomized, prospective, parallel, double-blind study. Study duration is approximately 16 weeks.At Visit 2 (Baseline Visit), all eligible study subjects will be randomized to one of two treatment groups: intramuscular Botox plus oral placebo, or intramuscular placebo plus oral baclofen.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Spasticity

Intervention

Drug: intramuscular Botox versus oral baclofen

Each vial of Botox contains 100 units of Clostridium botulinum toxin type A, 0.5 mg albumin (human) and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. Botox placebo is sterile normal saline (without preservatives) for injection. Baclofen is supplied as 10 mg tablets for oral administration. Inactive ingredients include colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch. Baclofen placebo tablets are composed of microcrystalline cellulose binder (99%), magnesium stearate 0.5%, and silica gel 0.5% and appear similar to commercial Baclofen tablets.

Study Arms

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.

Intervention: Drug: intramuscular Botox versus oral baclofen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 19, 2012): 8
• Original Enrollment (submitted: January 18, 2006): 30
• Actual Study Completion Date: February 2009
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and are not practicing a reliable method of birth control.
• Severe contracture at the wrist or a history of tendon transfer in the study limb.
• Cast of study limb within four weeks of Visit 1.
• Profound atrophy of the muscles in the target area(s) of injection.
• Progressive neurological disorder (e.g., multiple sclerosis).
• Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
• Orthostatic hypotension or current use of alpha-2 adrenergic agonists (e.g. clonidine).
• Current anticoagulant therapy and INR > 3.5
• Significantly impaired renal and/or hepatic function, in the opinion of the Investigator.
• Failure to meet prohibited concomitant medication criteria (Supplement I)
• Subjects planning inpatient surgery during the study.
• Any uncontrolled systemic disease.
• Allergy or sensitivity to any component of the study medication.
• Recent alcohol or drug abuse.
• History of poor cooperation, non-compliance with medical treatment, or unreliability.
• Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00280280
• Other Study ID Numbers: 050935
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: David Charles, Vanderbilt University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Vanderbilt University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: P. David Charles, MD; Vanderbilt University Department of Neurology

• PRS Account: Vanderbilt University
• Verification Date: January 2012