Botulinum Toxin A Adult Gastrocnemius Muscle Study

NCT01278576 | Completed Phase 4 DMC

• 1 other identifier: BCMC10AH07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.

Conditions

Muscle Spasticity; Stroke

Keywords

Muscle spasticity; Stroke; Botulinum Toxins; Lower extremity; Ankle

Outcome Measures

Primary Outcomes (1)

• Change from baseline for EMG (electromyogram) activity

  Surface EMG

  week 8

Secondary Outcomes (8)

• Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS)

  Change from baseline at 8 weeks

• Change from baseline of Ankle Range of motion

  Change from baseline at 8 weeks

• Change from baseline of gait speed with 10 meters walk test

  Change from baseline at 8 weeks

• Change from baseline of ABILOCO scale

  Change from baseline at 8 weeks

• Change from baseline of Disability Assessment Scale

  Change from baseline at 8 weeks

Study Arms (2)

Intramuscular ending Targeting

EXPERIMENTAL

Botox 200 units placed at the upper 2/10-3/10 length of the GCM

Drug: BOTOX-A®

Midbelly Targeting

ACTIVE COMPARATOR

A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM.

Drug: BOTOX-A®

Interventions

BOTOX-A® DRUG

200 units, single treatment only

Also known as: Generic Name: Botulinum toxin type A

Intramuscular ending Targeting; Midbelly Targeting

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 20 \< age \< 70 year old
• Hemiplegia documented after ischemic or hemorrhagic stroke, documented by CT (computed tomography) or MRI (magnetic resonance imaging) scan
• Time between the onset of stroke \< 24 months
• Individuals who have been medically stable for at least 4 weeks prior to study enrollment
• Confirmed equinovarus with spastic hypertonia of the ankle
• Spasticity as defined by a MAS greater than grade 1 +
• Botulinum toxin -naive patients
• Participants who can complete the 10 meter walking test with caregiver or walking tool assistance within 8 and 45 seconds, on 2 occasions
• Participants who will have stable treatment regimen and concomitant medication during the trial period

You may not qualify if:

• The patient has any of the following medical conditions that is contraindication to botulinum toxin exposure; pregnancy, lactation, neuromuscular disease, aminoglycoside, antibiotic concurrent to botulinum toxin treatment
• Fixed contracture of the ankle, previous history of surgical procedure performed on the ankle
• Cognitive deficit that disables patients to give informed consent to the procedure
• Concomitant progression of any CNS (central nervous system) or PNS (peripheral nervous system), or myopathy, or uncontrolled seizure. Underlying CNS insult should be controlled and in stable condition with no further risk of progression and further deterioration of patient's current neurological status. Those with multiple sclerosis or multiple systemic atrophy are to be excluded
• Significant cutaneous or joint inflammation
• URI or other systemic infection that would mandate the use of antibiotic concurrent to botulinum toxin injection
• Anticoagulation treatment with INR (International Normalized Ratio) greater than 3.0
• Upper extremity spasticity greater than MAS grade 4 that may limit gait function
• Subjects with previous episodes of motor point block injection using phenol or other chemodenervating agents
• Subjects with intrathecal baclofen pump

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Bobath Memorial Hospital: collaborator

Study Sites (2)

Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

Bucheon-si, Kyounggido, South Korea

Location

Bobath Memorial Hospital

Songnam, Kyoungido, South Korea

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

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

Study Officials

• Sun Im, MD, PhD

  Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: May 15, 2012

Record last verified: 2011-01

Locations

KR (2)