Clinical trial NCT01313767: MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spasticity
Keywords: spasticity
upperlimb
Botulinum toxin
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 196
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: MAS(Modified Ashworth Scale) of Wrist Flexor
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: MAS(Modified Ashworth Scale) of Wrist Flexor
timeFrame: Baseline, week 8 and week 12
measure: MAS(Modified Ashworth Score) of Elbow Flexor
timeFrame: Baseline, week 4, week 8 and week 12
measure: MAS(Modified Ashworth Score) of Finger Flexor
timeFrame: Baseline, week 4, week 8 and week 12
measure: MAS(Modified Ashworth Score) of Thumb Flexor
timeFrame: Baseline, week 4, week 8 and week 12
measure: Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor
timeFrame: week 4, week 8, week 12
measure: Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor
timeFrame: week 4, week 8, week 12
measure: Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor
timeFrame: week 4, week 8, week 12
measure: Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor
timeFrame: week 4, week 8, week 12
measure: DAS(Disability Assessment Scale) of Hygiene
timeFrame: Baseline, week 4, week 8 and week 12
measure: DAS(Disability Assessment Scale) of Dressing
timeFrame: Baseline, week 4, week 8 and week 12
measure: DAS(Disability Assessment Scale) of Limb Position
timeFrame: Baseline, week 4, week 8 and week 12
measure: DAS(Disability Assessment Scale) of Pain
timeFrame: Baseline, week 4, week 8 and week 12
measure: Global Assessment by Investigator
timeFrame: week 12
measure: Global Assessment by Patient or Caregiver
timeFrame: week 12
measure: Carer Burden Scale of Cleaning the Palm
timeFrame: Baseline, week 4, week 8 and week 12
measure: Carer Burden Scale of Cutting the Finger-nails
timeFrame: Baseline, week 4, week 8 and week 12
measure: Carer Burden Scale of Putting Shirts on
timeFrame: Baseline, week 4, week 8 and week 12
measure: Carer Burden Scale of Cleaning the Armpit
timeFrame: Baseline, week 4, week 8 and week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National Universtiy Hospital, 101 Daehak-ro Jong-gu, Seoul 110-744, Korea
name: Moon Suk Bang, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center, 388-1 Pungnap-2 dong, Songpa-Gu, Seoul, 138-736, Korea
name: Min Ho Chun, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University Bundang Hospital, Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea
name: Nam Jong Baik, Ph. D
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu, Seoul, 156-707, Seoul, Korea
name: Si Uk Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongguk University International Hospital, Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea
name: Beom Seon Gwon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.