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

Spasticity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313767
• Other study ID #: MT-PRT-ST01
• Status: Completed
• Phase: Phase 3
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: February 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Intervention

Drug:
• Botulinum toxin type A
Botulinum toxin type A
• Botulinum Toxin type A
Botulinum Toxin type A

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MAS(Modified Ashworth Scale) of Wrist Flexor	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).	Baseline, week 8 and week 12
Secondary	MAS(Modified Ashworth Score) of Elbow Flexor	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).	Baseline, week 4, week 8 and week 12
Secondary	MAS(Modified Ashworth Score) of Finger Flexor	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).	Baseline, week 4, week 8 and week 12
Secondary	MAS(Modified Ashworth Score) of Thumb Flexor	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).	Baseline, week 4, week 8 and week 12
Secondary	Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor	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.	week 4, week 8, week 12
Secondary	Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor	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	week 4, week 8, week 12
Secondary	Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor	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.	week 4, week 8, week 12
Secondary	Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor	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.	week 4, week 8, week 12
Secondary	DAS(Disability Assessment Scale) of Hygiene	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).	Baseline, week 4, week 8 and week 12
Secondary	DAS(Disability Assessment Scale) of Dressing	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).	Baseline, week 4, week 8 and week 12
Secondary	DAS(Disability Assessment Scale) of Limb Position	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).	Baseline, week 4, week 8 and week 12
Secondary	DAS(Disability Assessment Scale) of Pain	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).	Baseline, week 4, week 8 and week 12
Secondary	Global Assessment by Investigator	Global assessment evaluated by investigator at week 12 after injection	week 12
Secondary	Global Assessment by Patient or Caregiver	Global assessment evaluated by patient or caregiver at week 12 after injection	week 12
Secondary	Carer Burden Scale of Cleaning the Palm	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).	Baseline, week 4, week 8 and week 12
Secondary	Carer Burden Scale of Cutting the Finger-nails	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).	Baseline, week 4, week 8 and week 12
Secondary	Carer Burden Scale of Putting Shirts on	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).	Baseline, week 4, week 8 and week 12
Secondary	Carer Burden Scale of Cleaning the Armpit	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).	Baseline, week 4, week 8 and week 12