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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
  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:


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 ]

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 ]
  • To describe tremor change score from inclusion (TSUI scale) [ Time Frame: Baseline, and around 4 weeks and 3 months post injection ]
  • To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion [ Time Frame: Baseline, and around 4 weeks post injection ]
  • To describe subject and investigator's CGI scores [ Time Frame: Around 4 weeks post injection ]
  • To identify prognostic factors for response (Exploratory Objective) [ Time Frame: baseline, and around 4 weeks and 3 months post injection ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00833196

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

ClinicalTrials.gov processed this record on June 28, 2017