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Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02757404
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

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

Condition or disease Intervention/treatment Phase
Muscle Spasticity Drug: Ultrasonography guidance injection of Meditoxin®. Drug: Electrical stimulation guidance injection of Meditoxin®. Drug: Manual needle placement injection of Meditoxin®. Phase 4

Detailed 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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity
Actual Study Start Date : May 30, 2016
Actual Primary Completion Date : August 16, 2016
Actual Study Completion Date : August 16, 2016

Arm Intervention/treatment
Experimental: Ultrasonography guidance
Ultrasonography guidance injection of Meditoxin®.
Drug: Ultrasonography guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.

Experimental: Electrical stimulation guidance
Electrical stimulation guidance injection of Meditoxin®.
Drug: Electrical stimulation guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.

Experimental: Manual needle placement
Manual needle placement injection of Meditoxin®.
Drug: Manual needle placement injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.




Primary Outcome Measures :
  1. Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757404


Sponsors and Collaborators
Medy-Tox
Investigators
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Principal Investigator: MyungEun Chung St. Paul's Hospital, The Catholic University of Korea

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT02757404     History of Changes
Other Study ID Numbers: MT_PRT_ST04
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medy-Tox:
botulinum toxin
spasticity
injection technique
neuronox
meditoxin

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents