Botox vs. Baclofen for Upper Limb Spasticity

NCT ID: NCT00280280

Last Updated: 2012-01-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-02-28

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.

Conditions

Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

intramuscular Botox versus oral baclofen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

David Charles

Associate Professor Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P. David Charles, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Department of Neurology

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

050935

Identifier Type: -

Identifier Source: org_study_id