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

NCT ID: NCT01313767

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-02-29

Brief 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).

Detailed 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.

Conditions

Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Meditoxin®

Botulinum toxin type A

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: DRUG

Botulinum toxin type A

Botox®

Botulinum Toxin type A

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin type A

Intervention Type: DRUG

Botulinum Toxin type A

Interventions

Botulinum toxin type A

Botulinum toxin type A

Intervention Type: DRUG

Botulinum Toxin type A

Botulinum Toxin type A

Intervention Type: DRUG

Other Intervention Names

Neuronox®, Siax®; Botox®

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moon Suk Bang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National Universtiy Hospital, 101 Daehak-ro Jong-gu, Seoul 110-744, Korea

Min Ho Chun, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center, 388-1 Pungnap-2 dong, Songpa-Gu, Seoul, 138-736, Korea

Nam Jong Baik, Ph. D

Role: PRINCIPAL_INVESTIGATOR

University Bundang Hospital, Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea

Si Uk Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu, Seoul, 156-707, Seoul, Korea

Beom Seon Gwon, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dongguk University International Hospital, Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

Seo HG, Paik NJ, Lee SU, Oh BM, Chun MH, Kwon BS, Bang MS. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial. PLoS One. 2015 Jun 1;10(6):e0128633. doi: 10.1371/journal.pone.0128633. eCollection 2015.

Reference Type: DERIVED

PMID: 26030192 (View on PubMed)

Other Identifiers

MT-PRT-ST01

Identifier Type: -

Identifier Source: org_study_id