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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
JoAnn Harnar, Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier:
NCT00945295
First received: March 30, 2009
Last updated: August 20, 2013
Last verified: August 2013
  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
Upper Limb Spasticity
Drug: Botulinum toxin type A, BoNT-A
Other: Rehabilitation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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 ]

Enrollment: 31
Study Start Date: January 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort #1
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
Active Comparator: Cohort #2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Mexico
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108
Sponsors and Collaborators
JoAnn Harnar
Allergan
Investigators
Principal Investigator: Glenn D. Graham, MD, PhD New Mexico VA Health Care System
  More Information

No publications provided

Responsible Party: JoAnn Harnar, Research Nurse, Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier: NCT00945295     History of Changes
Other Study ID Numbers: Allergan-100808
Study First Received: March 30, 2009
Results First Received: August 20, 2013
Last Updated: August 20, 2013
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:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014