Skip to main content
OpenTrials
Completed

NCT Number: NCT02757404

Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ultrasonography guidance injection of Meditoxin®.

Drug

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

Electrical stimulation guidance injection of Meditoxin®.

Drug

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

Manual needle placement injection of Meditoxin®.

Drug

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

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.

    Time frame: 4 weeks

  2. Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 2, 2016
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.