A randomized, double blind, multi-center, active drug controlled,phase III clinical trial to compare the safety and efficacy of BOTULAX® versus BOTOX® in treatment of post stroke upper limb spasticity.
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0001188
- Lead Sponsor
- Hugel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 186
1. Male or female subjects no younger than 20 years of age.
2. Patients diagnosed with stroke =6 weeks prior to enrollment in current study
3. Focal spasticity score = 2 points at wrist flexor and = 1 point at one or more of the following muscles: elbow flexor and/or finger flexor (scores measured on the MAS (0 to 4))
4. A minimum of grade 2 in the targeted functional disability item (i.e., hygiene, dressing, upper-limb position sense, or pain) on the Disability Assessment Scale (0 to 3)
5. Voluntary informed consent signed by patient or patient’s legal guardian after objective, methods, and efficacy of clinical study have been explained
1. Subjects who have a history of Neuromuscular Junction Disorders (Ex,Myasthenia Graris,Lambert-Eaton myasthenic syndrome, Congenital myasthenic syndrome)
2. Patients with significant atrophy of the muscle in the target limb
3. Patients with fixed joint/muscle contracture* in the target limb
* Defined as inability to passively move the joints
4. Prior (within 6 months of administration of study drug) or planned (during study period) treatment with phenol/alcohol injection (chemodenervation) in the target limb
5. Prior (within 6 months of administration of study drug) or planned (during study period) tendon lengthening surgery in the target limb
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of Modified Ashworth Scale (MAS) scores of wrist flexor evaluated by the investigator in weeks 4 from the Investigatioal Product injection
- Secondary Outcome Measures
Name Time Method Improvement of Modified Ashworth Scale (MAS) scores of elbow flexor, finger flexor, thumb flexor evaluated by the investigator in weeks 4 from the Investigatioal Product injection;Improvement of Modified Ashworth Scale (MAS) scores of wrist flexor, elbow flexor, finger flexor, thumb flexor evaluated by the investigator in weeks 8,12 from the Investigatioal Product injection;Laboratory Tests;Vital Signs (Blood pressure, pulse and temperature)