An observational study in Idiopathic Cervical Dystonia, sponsored by Ipsen. Completed at 39 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-16.
Sponsored by Ipsen · Observational
A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's enrollment of 404 is above the median of 60 across 126 observational studies indexed under Dystonia.
Browse Dystonia studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with idiopathic cervical dystonia
Exclusion Criteria:
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Time frame: Around 4 weeks post injection
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Time frame: Baseline, and around 4 weeks and 3 months post injection
To describe tremor change score from inclusion (TSUI scale)
Time frame: Baseline, and around 4 weeks and 3 months post injection
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Time frame: Baseline, and around 4 weeks post injection
To describe subject and investigator's CGI scores
Time frame: Around 4 weeks post injection
To identify prognostic factors for response (Exploratory Objective)
Time frame: baseline, and around 4 weeks and 3 months post injection
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Ipsen