MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity

Spasticity, Muscle Clinical Trial

Official title:

A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908580
• Other study ID #: MT_PRT_ST02
• Status: Completed
• Phase: Phase 4
• Start date: September 6, 2013
• Est. completion date: March 31, 2015

Study information

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

Clinical Trial Summary

This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2015
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Male or female over 20 years.

2. Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.

3. Subjects with MAS score of =2 for local muscle spasticity of wrist flexor.

Exclusion Criteria:

1. Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).

2. Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.

3. Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.

4. Known immunization or hypersensitivity to any botulinum toxin preparations.

5. Subjects who have recieved the following treatments within 4 weeks from screening:

Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Intervention

Drug:
• Meditoxin
Meditoxin® (Botulinum toxin type A) was injected up to 360 U.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor	Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.	4 weeks
Secondary	Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor	Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of elbow flexor and finger flexor at week 4 and 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.	4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary	Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor	Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.	16 weeks, and 4 weeks after re-visit
Secondary	The effective rate of wrist flexor, elbow flexor, and finger flexor	The effective rate of wrist flexor, elbow flexor, and finger flexor at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit, defining the muscle with MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) score of =1 among the wrist flexor, elbow flexor, and finger flexor muscles as responders when the MAS is reduced by 1 score compared to baseline (week 0).	4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary	Change in DAS (Disability Assessment Scale) score	Change in score of goal assessment section in DAS (Disability Assessment Scale: Measures disability associated with upper limb spasticity in patients; score 0 to 3, 3 being the most severe disability) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.	4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary	Change in QOL (SF-36v2; Quality of Life) score	Change in score of Short Form 36 ver.2 (SF-36v2; Quality of Life, QOL: a questionnaire with 36 questions regarding general health change affecting patient's quality of life; score from 1 up to 5, from minimum to high impact on quality of life) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.	4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary	Subject's or caregiver's global assessment	Subject's or caregiver's global assessment (rating from -3 to +3 on the overall treatment effect, with +3 being very satisfied with treatment) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.	4 weeks, 16 weeks, and 4 weeks after re-visit
Secondary	Number of participants with Adverse Events (AEs) to assess safety of investigational product.	Safety of IP assessed by the number of partiicipants with adverse events determined by MedDra ver 16.0 from enrollment to the end of study.	Through study completion, an average of 1 year