A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753310
First received: December 17, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.


Condition Intervention Phase
Cervical Dystonia
Drug: Dysport
Drug: Placebo, Up to 2mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: 4 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in TWSTRS total score [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGIC) in Cervical Dystonia [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
  • Treatment response [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
    A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment.

  • Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dysport
Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Drug: Dysport
Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Placebo Comparator: Placebo
Up to 2mL
Drug: Placebo, Up to 2mL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
  • TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

  • In apparent remission from Cervical Dystonia
  • Diagnosis of pure retrocollis or pure anterocollis
  • For non-naïve subjects, previous poor response to either of the last two Botox treatments
  • Known requirement of <100U or >200U of Botox injected into the neck muscles
  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: NCT01753310

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 45 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Kathleen G Lomax, M.D. Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01753310     History of Changes
Other Study ID Numbers: A-TL-52120-169
Study First Received: December 17, 2012
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug 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
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014