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Completed

NCT Number: NCT01314365

DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

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

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Dystonia Institute, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: ANCHOR-CD

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Mar 14, 2011
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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