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

This study is currently recruiting participants.
Verified February 2013 by Medy-Tox
Sponsor:
Information provided by (Responsible Party):
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01588574
First received: April 24, 2012
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Dystonia
U.S. FDA Resources

Further study details as provided by Medy-Tox:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588574

Contacts
Contact: HyunJee Kim +82 70 8666 7516 claire56@medytox.com

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

No publications provided

Responsible Party: Medy-Tox
ClinicalTrials.gov Identifier: NCT01588574     History of Changes
Other Study ID Numbers: MT-GPRT-CD01
Study First Received: April 24, 2012
Last Updated: February 19, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013