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

This study has been completed.
Sponsor:
Information provided by:
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01313767
First received: March 10, 2011
Last updated: April 24, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Spasticity
 Drug: Botulinum toxin type A
Drug: Botulinum Toxin type A
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Multi-center, Active Drug Controlled Clinical Trial to Compare the Efficacy and Safety of MEDITOXIN® Versus BOTOX® in Treatment of Post Stroke Upper Limb Spasticity

Resource links provided by NLM:

MedlinePlus related topics: Botox Caregivers
U.S. FDA Resources

Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • MAS(Modified Ashworth Scale)of wrist flexor [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)


Secondary Outcome Measures:
  • MAS(Modified Ashworth Scale)of wrist flexor [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)

  • MAS(modified Ashworth Score)of elbow and finger flexor [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline at week 4, 8, 12 for elbow flexor and finger flexor muscle tone as measured on MAS

  • Responder rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Percentage of treatment responder at week 4, 8, 12 after injection

    * A treatment response is defined as 1-point improvement on the MAS of injection site


  • Disability Assessment Scale(DAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target

    * 4-point DAS is consisting of the 4 domains: hygiene, dressing, limb position, and pain.


  • Global assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Global assessment evaluated by investigator and patient/caregiver at week 12 after injection

  • Carer burden scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Change From Baseline to week 4, 8, 12 in the Carer Burden Scale(all four damains)

    The Carer Burden Scale include cleaning the palm of the affected hand, cutting the fingernails of the affected hand, cleaning the armpit of the affected arm, and putting the affected arm through a sleeve.



Enrollment: 196
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditoxin®
Botulinum toxin type A
 Drug: Botulinum toxin type A
Botulinum toxin type A
Other Name: Neuronox®, Siax®
Active Comparator: Botox®
Botulinum Toxin type A
 Drug: Botulinum Toxin type A
Botulinum Toxin type A
Other Name: Neuronox®, Siax®

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313767

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Medy-Tox
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Woo sun Lee, Medical director, Medical Dept.
ClinicalTrials.gov Identifier: NCT01313767     History of Changes
Other Study ID Numbers: MT-PRT-ST01
Study First Received: March 10, 2011
Last Updated: April 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Medy-Tox:
spasticity
upperlimb
Botulinum toxin

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
 Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013