Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

NCT02757404 | Completed Phase 4

• 1 other identifier: MT_PRT_ST04
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Muscle Spasticity

Keywords

botulinum toxin; spasticity; injection technique; neuronox; meditoxin

Outcome Measures

Primary Outcomes (1)

• Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.

  4 weeks

Secondary Outcomes (2)

• 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

Study Arms (3)

Ultrasonography guidance

EXPERIMENTAL

Ultrasonography guidance injection of Meditoxin®.

Drug: Ultrasonography guidance injection of Meditoxin®.

Electrical stimulation guidance

EXPERIMENTAL

Electrical stimulation guidance injection of Meditoxin®.

Drug: Electrical stimulation guidance injection of Meditoxin®.

Manual needle placement

EXPERIMENTAL

Manual needle placement injection of Meditoxin®.

Drug: Manual needle placement injection of Meditoxin®.

Interventions

Ultrasonography guidance injection of Meditoxin®. DRUG

Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.

Ultrasonography guidance

Electrical stimulation guidance injection of Meditoxin®. DRUG

Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.

Electrical stimulation guidance

Manual needle placement injection of Meditoxin®. DRUG

Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

Manual needle placement

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medy-Tox: lead

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MyungEun Chung

  St. Paul's Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 2, 2016
• Study Start: May 30, 2016
• Primary Completion: August 16, 2016
• Study Completion: August 16, 2016
• Last Updated: March 29, 2019

Record last verified: 2019-03