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

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ClinicalTrials.gov Identifier: NCT01314365
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

Condition or disease
Cervical Dystonia

Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DYSPORT™ for Injection AbobotulinumtoxinA Neurotoxin Clinical & Health Economics Outcomes Registry in Cervical Dystonia (ANCHOR-CD)
Study Start Date : April 2011
Primary Completion Date : November 2013
Study Completion Date : March 2014





Primary Outcome Measures :
  1. Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score [ Time Frame: Cycle 1 - Baseline and week 4 ]
  2. Patient Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Baseline and week 4 ]

Secondary Outcome Measures :
  1. Clinical Global Impression of Change using the 7-point Likert scale [ Time Frame: Cycle 1 - Week 4 and early termination visit ]
  2. 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 ]
  3. Time to Waning Effect of Dysport treatment/symptom re-emergence [ Time Frame: Cycles 1 to 4 - Week 8 and at study termination visits ]
  4. Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58) [ Time Frame: Cycles 1 & 3: Baseline ]
  5. 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 ]
  6. Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit ]


Information from the National Library of Medicine

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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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314365


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

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01314365     History of Changes
Other Study ID Numbers: A-TL-52120-156
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs