Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

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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

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®.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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