Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia [CD-NIS-Longterm]
CDNISLongterm
A National, Multicenter, Non-interventional, Prospective, Longitudinal Study for Treatment With Botulinum Toxin A Injections in naïve and Pre-treated Patients Suffering From Cervical Dystonia (Dysport®)
1 other identifier
observational
372
2 countries
2
Brief Summary
The objective of this study is to investigate the efficacy of Dysport® in the treatment of cervical dystonia (CD) in a non-interventional long-term study in naïve and pre-treated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJanuary 14, 2019
January 1, 2019
3.3 years
April 23, 2013
January 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Tsui scores
The Tsui rating scale is a disease-specific score to evaluate the severity of CD taking the clinical signs of CD into account in a standardised manner.
Baseline and 12 weeks post-injection Cycle 2
Secondary Outcomes (3)
Change in Tsui scores
Baseline and 12 weeks post-injection Cycle 1
Change in Tsui scores
Baseline and 12 weeks post-injection Cycle 3
Change in Tsui scores
Baseline and 12 weeks post-injection Cycle 4
Study Arms (2)
Subjects naïve to botulinum toxin A (BoNT-A) treatment
Patients naïve to botulinum toxin A treatment
Subjects pre-treated with botulinum toxin A (BoNT-A) injection
Patients pre-treated with botulinum toxin A for at least 2 years. 4 injection cycles, each at 3 to 4 months intervals. Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics).
Eligibility Criteria
Patients suffering from cervical dystonia
You may qualify if:
- Suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component
- With the intention to be treated with Dysport®
You may not qualify if:
- The subject has already been included in this study
- Participation in an interventional trial
- Suffering from anterocollis or retrocollis as primary component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (2)
Unknown Facility
Graz, Austria
Unknown Facility
Wiesbaden, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
July 1, 2012
Primary Completion
November 1, 2015
Study Completion
March 1, 2016
Last Updated
January 14, 2019
Record last verified: 2019-01