DYSPORT™ Clinical & Health Economics Outcomes Registry in Cervical Dystonia

Completed

• Conditions: Cervical Dystonia

• Registration Number: NCT01314365
• Lead Sponsor: Ipsen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Study Start: 2011-04
• Primary Completion: 2013-11
• Study Completion: 2014-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of treatment responders using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity scale score	Cycle 1 - Baseline and week 4
Patient Global Impression of Change using the 7-point Likert scale	Cycle 1 - Baseline and week 4

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Change using the 7-point Likert scale	Cycle 1 - Week 4 and early termination visit
Patient Global Impression of Change using the 7-point Likert scale	Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visits
Time to Waning Effect of Dysport treatment/symptom re-emergence	Cycles 1 to 4 - Week 8 and at study termination visits
Patient-self-administered questionnaire (Cervical Dystonia Impact Profile-58)	Cycles 1 & 3: Baseline
Patient-reported assessment of pain using the Pain Numeric Rating Scale (NRS)	Cycles 1 to 4 - Baseline, week 4 and at study termination visits
Treatment Satisfaction Questionnaire for Medication (TSQM)	Cycle 1 - Week 4; Cycles 2 to 4 - Baseline, week 4 and termination visit

Trial Locations

Locations (45)

Arizona Dystonia Institute; 🇺🇸 Scottsdale, Arizona, United States

East Bay Physicians Medical Group; 🇺🇸 Berkeley, California, United States

Headache Center; 🇺🇸 Encinitas, California, United States

The Parkinson's & Movement Disorder Institute; 🇺🇸 Fountain Valley, California, United States

Neuro-Pain Medical Center; 🇺🇸 Fresno, California, United States

Coastal Neurological Medical Group, Inc.; 🇺🇸 La Jolla, California, United States

Valley Parkinson Clinic; 🇺🇸 Los Gatos, California, United States

Harvinder S. Birk; 🇺🇸 Redding, California, United States

Colorado Springs Neurological Associates; 🇺🇸 Colorado Springs, Colorado, United States

University of Colorado Denver; 🇺🇸 Denver, Colorado, United States

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