Phase 3
N=196
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01313767 ↗Enrolled (actual)
196
Serious AEs
6.6%
Results posted
Mar 2019
Primary outcome: Primary: MAS(Modified Ashworth Scale) of Wrist Flexor — 2.41; 2.52; 1.02; 0.96 Scores on a MAS Scale — p=0.1347
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Medy-Tox
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MAS(Modified Ashworth Scale) of Wrist Flexor |
2.41; 2.52; 1.07; 1.04; 1.16; 1.16 | 0.2591 |
| SECONDARY MAS(Modified Ashworth Scale) of Wrist Flexor |
2.41; 2.52; 1.07; 1.04; 1.16; 1.16 | 0.2591 |
| SECONDARY MAS(Modified Ashworth Score) of Elbow Flexor |
2.33; 2.18; 1.26; 1.30; 1.36; 1.41 | 0.0675 |
| SECONDARY MAS(Modified Ashworth Score) of Finger Flexor |
2.37; 2.48; 1.01; 1.05; 1.15; 1.17 | 0.6954 |
| SECONDARY MAS(Modified Ashworth Score) of Thumb Flexor |
1.94; 1.94; 0.89; 0.69; 1.01; 0.84 | 0.2284 |
| SECONDARY Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor |
77; 88; 77; 80; 71; 77 | 0.1585 |
| SECONDARY Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor |
56; 52; 49; 42; 46; 39 | 0.1802 |
| SECONDARY Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor |
58; 64; 51; 60; 47; 54 | 0.3431 |
| SECONDARY Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor |
34; 41; 28; 37; 27; 30 | 0.4623 |
| SECONDARY DAS(Disability Assessment Scale) of Hygiene |
2.62; 2.74; 1.90; 2.09; 1.85; 2.12 | 0.6040 |
| SECONDARY DAS(Disability Assessment Scale) of Dressing |
2.09; 2.13; 1.30; 1.07; 1.36; 1.00 | 0.1220 |
| SECONDARY DAS(Disability Assessment Scale) of Limb Position |
2.50; 2.45; 1.28; 1.29; 1.27; 1.25 | 0.5030 |
| SECONDARY DAS(Disability Assessment Scale) of Pain |
2.00; 2.00; 1.25; 1.00; 0.75; 1.00 | 0.7237 |
| SECONDARY Global Assessment by Investigator |
19; 19; 63; 56; 10; 18 | 0.2346 |
| SECONDARY Global Assessment by Patient or Caregiver |
11; 10; 39; 44; 36; 35 | 0.9513 |
| SECONDARY Carer Burden Scale of Cleaning the Palm |
1.70; 1.67; 1.26; 1.34; 1.24; 1.40 | 0.8088 |
| SECONDARY Carer Burden Scale of Cutting the Finger-nails |
2.08; 2.22; 1.58; 1.89; 1.57; 1.84 | 0.9634 |
| SECONDARY Carer Burden Scale of Putting Shirts on |
1.79; 1.64; 1.46; 1.42; 1.34; 1.28 | 0.9362 |
| SECONDARY Carer Burden Scale of Cleaning the Armpit |
1.98; 1.97; 1.56; 1.71; 1.50; 1.59 | 0.7014 |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01313767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.