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

NCT01313767 | Completed Phase 3 Results

• 1 other identifier: MT-PRT-ST01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Spasticity

Keywords

spasticity; upperlimb; Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• MAS(Modified Ashworth Scale) of Wrist Flexor

  Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).

  Baseline and 4 weeks

Secondary Outcomes (18)

• MAS(Modified Ashworth Scale) of Wrist Flexor

  Baseline, week 8 and week 12

• MAS(Modified Ashworth Score) of Elbow Flexor

  Baseline, week 4, week 8 and week 12

• MAS(Modified Ashworth Score) of Finger Flexor

  Baseline, week 4, week 8 and week 12

• MAS(Modified Ashworth Score) of Thumb Flexor

  Baseline, week 4, week 8 and week 12

• Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor

  week 4, week 8, week 12

Study Arms (2)

Meditoxin®

EXPERIMENTAL

Botulinum toxin type A

Drug: Botulinum toxin type A

Botox®

ACTIVE COMPARATOR

Botulinum Toxin type A

Drug: Botulinum Toxin type A

Interventions

Botulinum Toxin type A DRUG

Botulinum toxin type A

Also known as: Neuronox®, Siax®

Meditoxin®

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 20 years
• ≥ 6 weeks since the last stroke
• ≥ 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)
• Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3)
• Informed consent has been obtained.

You may not qualify if:

• Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
• History(within 6 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
• History(within 6 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
• Fixed joint/muscle contracture
• Severe atrophy
• Concurrent treatment with an intrathecal baclofen
• History(within 3 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
• Known allergy or sensitivity to study medication or its components
• 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.
• 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.
• Patient who are participating in other clinical trials at the screening
• 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.
• Patients who are not eligible for this study at the discretion of the investigator.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26030192 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Botulinum Toxins, Type A; 3-deoxyglycero-galacto-nonulosonic acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Medytox Inc.
• Organization: Clinical Development Team of Medytox Inc.

hgpark@medytox.com

82-70-8666-6911

Study Officials

• Moon Suk Bang, Ph.D

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

  PRINCIPAL INVESTIGATOR

• Min Ho Chun, Ph.D

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

  PRINCIPAL INVESTIGATOR

• Nam Jong Baik, Ph. D

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

  PRINCIPAL INVESTIGATOR

• Si Uk Lee, Ph.D

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

  PRINCIPAL INVESTIGATOR

• Beom Seon Gwon, Ph.D

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 29, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03

Locations

KR (1)