Botox vs. Baclofen for Upper Limb Spasticity - Full Text View

Sponsor:	Vanderbilt University
Information provided by (Responsible Party):	David Charles, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00280280

Purpose

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.

Condition	Intervention	Phase
Spasticity	Drug: intramuscular Botox versus oral baclofen	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Botox Neurologic Diseases

Drug Information available for: Botulinum toxin A Baclofen

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Disability Assessment Scale (DAS) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Ashworth Tone [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Subject Questionnaires [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Contralateral Finger Tap Test [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Contralateral Grip Strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	February 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.

Arms

Assigned Interventions

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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280280

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2551

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

P. David Charles, MD

Vanderbilt University Department of Neurology

More Information

No publications provided

Responsible Party:	David Charles, Associate Professor Neurology, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00280280 History of Changes
Other Study ID Numbers:	050935
Study First Received:	January 18, 2006
Last Updated:	January 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

spasticity
Botox
baclofen

Additional relevant MeSH terms:

Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Baclofen
Botulinum Toxins, Type A
GABA-B Receptor Agonists

GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012