- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280280
Botox vs. Baclofen for Upper Limb Spasticity
Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-2551
- Vanderbilt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disability Assessment Scale (DAS)
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Ashworth Tone
Time Frame: 4 months
|
4 months
|
Subject Questionnaires
Time Frame: 4 months
|
4 months
|
Contralateral Finger Tap Test
Time Frame: 4 months
|
4 months
|
Contralateral Grip Strength
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: P. David Charles, MD, Vanderbilt University Department of Neurology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Muscle Hypertonia
- Muscle Spasticity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- GABA Agents
- Neuromuscular Agents
- Muscle Relaxants, Central
- GABA Agonists
- GABA-B Receptor Agonists
- Baclofen
Other Study ID Numbers
- 050935
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spasticity
-
Vancouver Island Health AuthorityRecruiting
-
Universitatea de Medicina si Farmacie Iuliu HatieganuRecruiting
-
Nantes University HospitalCompiègne University of TechnologyCompleted
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingSpasticity, Muscle
-
Piramal Critical Care, Ltd.CompletedSevere SpasticityUnited States
-
University of AlbertaRecruiting
-
Ospedale Generale Di Zona Moriggia-PelasciniSuspended
-
IpsenRecruitingUpper Limb SpasticityUnited States, France, Canada, Puerto Rico
-
IRCCS Sacro Cuore Don Calabria di NegrarRecruiting
-
Pacira Pharmaceuticals, IncCompletedUpper Limb SpasticityUnited States
Clinical Trials on intramuscular Botox versus oral baclofen
-
University of Sao PauloCompleted
-
Shaare Zedek Medical CenterTerminatedCerebral PalsyIsrael
-
Federico II UniversityCompleted
-
University of MinnesotaParalyzed Veterans of America Research FoundationCompleted
-
Allaysis, LLCUniversity of MinnesotaUnknownIntravenous Baclofen
-
United States Naval Medical Center, San DiegoUnknownChronic Rhinosinusitis (Diagnosis) | Antibiotic Side Effect
-
North Estonia Medical CentreTartu University HospitalRecruitingAcute Appendicitis | Appendicitis Acute | Appendicitis Perforated | Acute Appendicitis With Rupture | Appendicitis; Perforation | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessEstonia
-
Clinical Research Associates, LLCRecruiting16P11.2 Deletion SyndromeUnited States
-
King's College LondonCompletedAutism Spectrum DisorderUnited Kingdom
-
Gerencia de Atención Primaria, MadridInstituto de Salud Carlos IIICompleted