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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medy-Tox
ClinicalTrials.gov Identifier:
NCT01588574
First received: April 24, 2012
Last updated: September 5, 2014
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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588574

Locations
Australia
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: September 5, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014