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

NCT00945295 | Completed Results

• 1 other identifier: Allergan-100808
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Upper Limb Spasticity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Weeks

Secondary Outcomes (1)

• 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.

  6 Weeks

Study Arms (2)

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; Other: Rehabilitation Therapy

Cohort #2

ACTIVE COMPARATOR

Cohort 2 will receive BoNT-A alone

Drug: Botulinum toxin type A, BoNT-A

Interventions

Botulinum toxin type A, BoNT-A DRUG

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).

Cohort #1; Cohort #2

Rehabilitation Therapy OTHER

Rehabilitation therapy

Cohort #1

Eligibility Criteria

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

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• JoAnn Harnar: lead
• Allergan: collaborator

Study Sites (1)

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

This has a single-blind design. Admittedly, a double-blind design is best, but the participants could not be blind to the assignment of rehabilitation. Secondly, the study involved a relatively small sample size and limited follow-up duration.

Results Point of Contact

• Title: JoAnn Harnar, Research Nurse
• Organization: New Mexico VA Healthcare System

Joann.Harnar@va.gov

505-256-5701

Study Officials

• Glenn D. Graham, MD, PhD

  New Mexico VA Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Nurse

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: July 24, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 1, 2013
• Results First Posted: November 1, 2013

Record last verified: 2013-08

Locations

US (1)