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Completed

NCT Number: NCT01313767

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

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).

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Botulinum Toxin Type A

Drug

Botulinum toxin type A

Other names: Neuronox®, Siax®

Primary outcomes

  1. MAS(Modified Ashworth Scale) of Wrist Flexor

    Time frame: Baseline and 4 weeks

    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).

Secondary outcomes

  1. MAS(Modified Ashworth Scale) of Wrist Flexor

    Time frame: Baseline, week 8 and week 12

    Change from baseline at week 8 and 12 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).

  2. MAS(Modified Ashworth Score) of Elbow Flexor

    Time frame: Baseline, week 4, week 8 and week 12

    Change from baseline at week 4, week 8 and 12 for elbow 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).

  3. MAS(Modified Ashworth Score) of Finger Flexor

    Time frame: Baseline, week 4, week 8 and week 12

    Change from baseline at week 4, week 8 and 12 for finger 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).

  4. MAS(Modified Ashworth Score) of Thumb Flexor

    Time frame: Baseline, week 4, week 8 and week 12

    Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS.

    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).

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

    Time frame: week 4, week 8, week 12

    Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor.

    • A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.

  6. Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor

    Time frame: week 4, week 8, week 12

    Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor.

    • A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site

  7. Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor

    Time frame: week 4, week 8, week 12

    Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor.

    • A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.

  8. Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor

    Time frame: week 4, week 8, week 12

    Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor.

    • A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.

  9. DAS(Disability Assessment Scale) of Hygiene

    Time frame: Baseline, week 4, week 8 and week 12

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

    The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

  10. DAS(Disability Assessment Scale) of Dressing

    Time frame: Baseline, week 4, week 8 and week 12

    Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

  11. DAS(Disability Assessment Scale) of Limb Position

    Time frame: Baseline, week 4, week 8 and week 12

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

    The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

  12. DAS(Disability Assessment Scale) of Pain

    Time frame: Baseline, week 4, week 8 and week 12

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

    The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).

  13. Global Assessment by Investigator

    Time frame: week 12

    Global assessment evaluated by investigator at week 12 after injection

  14. Global Assessment by Patient or Caregiver

    Time frame: week 12

    Global assessment evaluated by patient or caregiver at week 12 after injection

  15. Carer Burden Scale of Cleaning the Palm

    Time frame: Baseline, week 4, week 8 and week 12

    The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

  16. Carer Burden Scale of Cutting the Finger-nails

    Time frame: Baseline, week 4, week 8 and week 12

    The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

  17. Carer Burden Scale of Putting Shirts on

    Time frame: Baseline, week 4, week 8 and week 12

    The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

  18. Carer Burden Scale of Cleaning the Armpit

    Time frame: Baseline, week 4, week 8 and week 12

    The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2011
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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