Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Medytox

Status and phase: Completed; Phase 4

Conditions: Muscle Spasticity

Treatments: Drug: Ultrasonography guidance injection of Meditoxin®.; Drug: Electrical stimulation guidance injection of Meditoxin®.; Drug: Manual needle placement injection of Meditoxin®.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02757404

MT_PRT_ST04

Details and patient eligibility

About

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

Full 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".

Enrollment: 59 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 3 patient groups

Ultrasonography guidance

Experimental group

Description:

Ultrasonography guidance injection of Meditoxin®.

Treatment:

Drug: Ultrasonography guidance injection of Meditoxin®.

Electrical stimulation guidance

Experimental group

Description:

Electrical stimulation guidance injection of Meditoxin®.

Treatment:

Drug: Electrical stimulation guidance injection of Meditoxin®.

Manual needle placement

Experimental group

Description:

Manual needle placement injection of Meditoxin®.

Treatment:

Drug: Manual needle placement injection of Meditoxin®.