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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: April 22, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Botox Dystonia
U.S. FDA Resources

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 ]

Estimated Enrollment: 400
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: April 22, 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 May 22, 2013