Botox vs. Baclofen for Upper Limb Spasticity

NCT00280280 | Terminated Phase 1

• 1 other identifier: 050935
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity

Keywords

spasticity; Botox; baclofen

Outcome Measures

Primary Outcomes (1)

• Disability Assessment Scale (DAS)

  4 months

Secondary Outcomes (4)

• Modified Ashworth Tone

  4 months

• Subject Questionnaires

  4 months

• Contralateral Finger Tap Test

  4 months

• Contralateral Grip Strength

  4 months

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

intramuscular Botox versus oral baclofen 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232-2551, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• P. David Charles, MD

  Vanderbilt University Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Neurology

Study Record Dates

• First Submitted: January 18, 2006
• First Posted: January 20, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

US (1)