Botox vs. Baclofen for Upper Limb Spasticity

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Spasticity

In brief

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.

Key facts

Study ID

NCT00280280

Run by

Vanderbilt University

People needed

8

Starts

2006-02-01

Expected to finish

2009-02-01

Last updated by the study team

2012-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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