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Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588574
First Posted: May 1, 2012
Last Update Posted: September 8, 2014
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.
Information provided by (Responsible Party):
Medy-Tox
  Purpose
The purpose of this study is to determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.

Condition Intervention Phase
Cervical Dystonia Biological: MT10109 Biological: BOTOX(Registered trade mark) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: Day 30 ]

Enrollment: 60
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BOTOX (registered trade mark) Biological: BOTOX(Registered trade mark)
Botulinum toxin type A
Experimental: MT10109 Biological: MT10109
Botulinum toxin type A

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18~75
  • Have no clinically significant medical condition
  • Cervical dystonia

Exclusion Criteria:

  • Pregnant or lactation
  • Subjects who have been administered the following drugs within the previous 1 month
  Contacts and Locations
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): NCT01588574


Locations
Australia
Brisbane, Australia
Sponsors and Collaborators
Medy-Tox
  More Information

Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT01588574     History of Changes
Other Study ID Numbers: MT-GPRT-CD01
First Submitted: April 24, 2012
First Posted: May 1, 2012
Last Update Posted: September 8, 2014
Last Verified: February 2013

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
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


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