Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Muscle Spasticity Clinical Trial

Official title:

Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757404
• Other study ID #: MT_PRT_ST04
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2016
• Est. completion date: August 16, 2016

Study information

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

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 16, 2016
• Est. primary completion date: August 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

Drug:
• Ultrasonography guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.
• Electrical stimulation guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.
• Manual needle placement injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.		4 weeks
Secondary	Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.		4 weeks
Secondary	Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.		4 weeks