Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Phase 4

Completed

• Conditions: Muscle Spasticity
• Interventions: Drug: Ultrasonography guidance injection of Meditoxin®.; Drug: Electrical stimulation guidance injection of Meditoxin®.; Drug: Manual needle placement injection of Meditoxin®.

• Registration Number: NCT02757404
• Lead Sponsor: Medy-Tox

Brief Summary

Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.

Detailed Description

This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• Study Start: 2016-05-30
• Primary Completion: 2016-08-16
• Study Completion: 2016-08-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Male or female subject aged over 20.
2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
3. Subjects who was diagnosed stroke at least 1 month prior to study participation.
4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.

Exclusion Criteria

1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
2. Subjects with allergy or hypersensitivity to the Botulinum Toxin.
3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
6. Subjects who have been injected with botulinum toxin within past 3 months before the injection.
7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
8. Subjects who are scheduled to take part in other clinical trial during the study period.
9. Patients who are not eligible for this study at the medical discretion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonography guidance	Ultrasonography guidance injection of Meditoxin®.	Ultrasonography guidance injection of Meditoxin®.
Electrical stimulation guidance	Electrical stimulation guidance injection of Meditoxin®.	Electrical stimulation guidance injection of Meditoxin®.
Manual needle placement	Manual needle placement injection of Meditoxin®.	Manual needle placement injection of Meditoxin®.

Primary Outcome Measures

Name	Time	Method
Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.	4 weeks
Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.	4 weeks