Botox vs. Baclofen for Upper Limb Spasticity

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: abobotulinumtoxinA; Baclofen; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.