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Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00833196
First received: January 29, 2009
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.


Condition
Idiopathic Cervical Dystonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

Resource links provided by NLM:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice [ Time Frame: Around 4 weeks post injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe TWSTRS change scores from inclusion (total score & subscales scores) [ Time Frame: Baseline, and around 4 weeks and 3 months post injection ] [ Designated as safety issue: No ]
  • To describe tremor change score from inclusion (TSUI scale) [ Time Frame: Baseline, and around 4 weeks and 3 months post injection ] [ Designated as safety issue: No ]
  • To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion [ Time Frame: Baseline, and around 4 weeks post injection ] [ Designated as safety issue: No ]
  • To describe subject and investigator's CGI scores [ Time Frame: Around 4 weeks post injection ] [ Designated as safety issue: No ]
  • To identify prognostic factors for response (Exploratory Objective) [ Time Frame: baseline, and around 4 weeks and 3 months post injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with idiopathic cervical dystonia

Criteria

Inclusion Criteria:

  • Idiopathic cervical dystonia
  • TWSTRS severity score ≥ 15
  • At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion
  • Written informed consent prior to collect the data

Exclusion Criteria:

  • Contraindications to any BoNT-A preparations
  • Secondary cervical dystonia
  • Subject already been included in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833196

  Show 39 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Benjamin Zakine, MD Ipsen
  More Information

No publications provided

Responsible Party: Benjamin Zakine, Ipsen
ClinicalTrials.gov Identifier: NCT00833196     History of Changes
Other Study ID Numbers: Y-79-52120-131
Study First Received: January 29, 2009
Last Updated: July 6, 2010
Health Authority: Australia: Human Research Ethics Committee
Portugal: Health Ethic Committee
France: French Data Protection Authority
Germany: Ministry of Health
Belgium: Institutional Review Board
Netherlands: Medical Ethics Review Committee (METC)
Czech Republic: State Institute for Drug Control
Russia: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Stress, Psychological
Torticollis
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013