MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity

Medytox

Status and phase: Completed; Phase 3

Conditions: Spasticity

Treatments: Drug: Botulinum toxin type A; Drug: Botulinum Toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01313767

MT-PRT-ST01

Details and patient eligibility

About

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).

Full description

Each completed subject will attend 4~5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U.

Enrollment: 196 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups

Meditoxin®

Experimental group

Description:

Botulinum toxin type A

Treatment:

Drug: Botulinum toxin type A

Botox®

Active Comparator group

Description:

Botulinum Toxin type A

Treatment:

Drug: Botulinum Toxin type A