Botulinum Toxin A Adult Gastrocnemius Muscle Study

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborator: Bobath Memorial Hospital
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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