DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01314365
First received: March 10, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The purpose of the protocol is to determine typical patient response to Dysport in the treatment of adult cervical dystonia (CD).


Condition
Cervical Dystonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score [ Time Frame: Cycle 1 - Baseline and week 4 ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Baseline and week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Week 4 and early termination visit ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits ] [ Designated as safety issue: No ]
  • Time to Waning Effect of Dysport treatment/symptom re-emergence [ Time Frame: Cycles 1 to 4 - Week 8 and at study termination visits ] [ Designated as safety issue: No ]
  • Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58) [ Time Frame: Cycles 1 & 3: Baseline ] [ Designated as safety issue: No ]
  • Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS) [ Time Frame: Cycles 1 to 4 - Baseline, week 4 and at study termination visits ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: April 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (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

Adult patients with Cervical Dystonia treated with Dysport

Criteria

Inclusion Criteria:

  • A diagnosis of idiopathic CD as determined by the enrolling investigator
  • If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study
  • Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews)
  • Provision of written informed consent prior to enrollment

Exclusion Criteria:

  • Contraindications to treatment with any BoNT-A or BoNT-B preparations
  • Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction
  • Anticipated concomitant treatment with BoNT for other than cervical dystonia
  • Secondary cervical dystonia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314365

  Show 45 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01314365     History of Changes
Other Study ID Numbers: A-TL-52120-156
Study First Received: March 10, 2011
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

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 April 16, 2014