Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity - Full Text View

Sponsor:	Biomedical Research Institute of New Mexico
Collaborator:	Allergan
Information provided by:	Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier:	NCT00945295

Purpose

The purpose of this study is to determine if a combination of botulinum neurotoxin A and rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in function based on the Fugl-Meyer and other validated measures.

Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.

Condition	Intervention
Focal Upper Limb Spasticity	Drug: Botulinum toxin type A, BoNT-A Other: Rehabilitation Therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open-label, Parallel Study to Determine the Efficacy and Safety of Botulinum Neurotoxin A Paired With Rehabilitation Therapy vs. Botulinum Neurotoxin A Alone for the Treatment of Post-stroke Upper Limb Spasticity

Resource links provided by NLM:

MedlinePlus related topics: Botox Rehabilitation

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Biomedical Research Institute of New Mexico:

Primary Outcome Measures:

The maximum change in Fugl-Meyer upper extremity score from the baseline exam to any post injection visit in each treatment arm. Comparison of the difference scores between the two groups will be considered significant at p < 0.05. [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Length of time to meet re-injection criteria and the number of participants that do not meet re-injection criteria prior to completion of the study. [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort #1: Active Comparator Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).	Drug: Botulinum toxin type A, BoNT-A Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis). Other: Rehabilitation Therapy Rehabilitation therapy
Cohort #2: Active Comparator Cohort 2 will receive BoNT-A alone	Drug: Botulinum toxin type A, BoNT-A Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).

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Eligibility

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

Criteria

Inclusion Criteria:

Adults 18 years of age or older
Stroke (ischemic or hemorrhagic) diagnosed by a neurologist at least 6 months prior to enrollment
Focal spasticity in upper limb measured at the elbow, wrist, fingers and thumb with a Modified Ashworth Scale (MAS) of 3 or greater in the wrist and/or fingers
Functional impairment secondary to spasticity such as difficulty with hygiene, dressing, posture or pain
Minimum weight of 44 kg (88 lbs) in order to tolerate the minimum required dosage of 200 U
Written informed consent has been obtained
Written authorization for Use and Release of Health and Research Study Information has been obtained
Laboratory findings required (if applicable)
Ability to follow study instructions and likely to complete all required visits
Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential). (If applicable.)

Exclusion Criteria:

Uncontrolled clinically significant medical condition other than the condition under evaluation
Known allergy or sensitivity to any of the components in the study medication
Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment
Fixed contracture or profound atrophy in the spastic limb
Prior or current treatment with neurolytic agents such as phenol or surgery; any version of botulinum toxin (other than BoNT-A more than 6 months prior to enrollment)
Current rehabilitation therapy that cannot be altered to the treatment plan in the study
Unable or unwilling to participate in a weekly rehab program
Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
Current treatment with agents affecting neuromuscular transmission
Evidence of recent alcohol or drug abuse
Infection or skin disorder at an anticipated injection site (if applicable)
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945295

Contacts

Contact: Glenn D. Graham, MD, PhD

(505)265-1711

Locations

United States, New Mexico
New Mexico VA Health Care System	Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Glenn D. Graham, MD, PhD 505-265-1711
Principal Investigator: Glenn D. Graham, MD, PhD
Sub-Investigator: Molly Kin, MD

Sponsors and Collaborators

Biomedical Research Institute of New Mexico

Allergan

Investigators

Principal Investigator:

Glenn D. Graham, MD, PhD

New Mexico VA Health Care System

More Information

No publications provided

Responsible Party:	New Mexico VA Healthcare System ( Glenn D. Graham, MD, Ph.D. )
Study ID Numbers:	Allergan-100808
Study First Received:	March 30, 2009
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00945295 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomedical Research Institute of New Mexico:

Cerebrovascular Accident/Rehabilitation
Muscle Spasticity
Botulinum Neurotoxin Type A
Post-stroke focal upper limb spasticity

Additional relevant MeSH terms:

Neuromuscular Manifestations
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Signs and Symptoms
Muscle Spasticity
Muscular Diseases

Botulinum Toxins
Musculoskeletal Diseases
Muscle Hypertonia
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010