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
  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:


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:
Torticollis
Dystonia
Dystonic Disorders
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 April 16, 2014