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Trial record 64 of 720 for:    Botulinum Toxins, Type A

Meditoxin® Treatment in Patients With Cervical Dystonia

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: NCT03232320
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medy-Tox

Brief Summary:
To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)

Condition or disease Intervention/treatment Phase
Dystonia Dystonic Disorder Drug: Meditoxin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia
Actual Study Start Date : July 6, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : November 5, 2018


Arm Intervention/treatment
Experimental: MEDITOXIN Drug: Meditoxin
Meditoxin (Botulinum toxin type A)

Placebo Comparator: Placebo Drug: Placebo
Placebo (Normal saline)




Primary Outcome Measures :
  1. Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline [ Time Frame: week 4 follow-up visit ]

Secondary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline [ Time Frame: week 4 follow-up visit ]
  2. Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline [ Time Frame: week 4 follow-up visit ]
  3. Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline [ Time Frame: week 4 follow-up visit ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 20 to less than 75 years
  • Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score >=20 and TWSTRS-Severity score >=10

Exclusion Criteria:

  • Subjects with pure anterocollis
  • Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
  • A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
  • Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study

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): NCT03232320


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Medy-Tox

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Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT03232320     History of Changes
Other Study ID Numbers: MT01-KR16CVD309
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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Botulinum Toxins, Type A
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents