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.
Verified February 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753310
First received: December 17, 2012
Last updated: February 26, 2014
Last verified: February 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 18 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≥ 30; TWSTRS-severity subscale score≥ 15;

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753310

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

  Show 44 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: February 26, 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 April 20, 2014