MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: Botulinum toxin type A; Botulinum Toxin type A
Intervention description: Botulinum toxin type A; Botulinum Toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: spasticity; upperlimb; Botulinum toxin

Summary:

      This study is a randomized, double blind, multi-center, active drug controlled, phase III
      clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of
      post stroke upper limb(wrist, finger, thumb) spasticity

      Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single
      treatment of intramuscular Investigational product up to 360U. The subjects will be observed
      every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale
      (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or
      caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change
      from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth
      Scale. Safety parameters will also be measured including adverse events, vital signs and
      clinical laboratory tests (haematology, serum chemistry and urinanalysis).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients ≥ 20 years

          2. ≥ 6 weeks since the last stroke

          3. ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points at least one of
             elbow flexor and finger flexor as measured on MAS(0 to 4)

          4. Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis)
             with a rating of 2 or greater on DAS (0 to 3)

          5. Informed consent has been obtained.

        Exclusion Criteria:

          1. Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or
             amyotrophic lateral sclerosis

          2. History(within 6 months of screening visit) or planned(during study period) treatment
             with phenol or alcohol injection or surgery in the target limb

          3. History(within 6 months of screening visit) or planned(during study period) treatment
             with tendon lengthening in the target limb

          4. Fixed joint/muscle contracture

          5. Severe atrophy

          6. Concurrent treatment with an intrathecal baclofen

          7. History(within 3 months of screening visit) Planned(during study period) treatment
             with Botulinum Toxin

          8. Known allergy or sensitivity to study medication or its components

          9. Concurrent or planed Muscle relaxants and/or benzodiazepine medication

               -  If patient has taken these medication stable from one month before screening and
                  no treatment changes are not planned during the study, participation is allowed.

         10. Current Physical, occupational, Splinting therapy

               -  If these therapy regimens will be permitted if they has been stable in the one
                  month before screening;no treatment and no changes are planned during the study.

         11. Patient who are participating in other clinical trials at the screening

         12. Females who are pregnant, breatfeeding,or planning a pregnancy during the study
             period, or female of childbearing potential, not using a reliable means of
             centraception.

         13. Patients who are not eligible for this study at the discretion of the investigator.