Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

Idiopathic Cervical Dystonia Clinical Trial

Official title:

An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833196
• Other study ID #: Y-79-52120-131
• Status: Completed
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic cervical dystonia

• TWSTRS severity score = 15

• At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion

• Written informed consent prior to collect the data

Exclusion Criteria:

• Contraindications to any BoNT-A preparations

• Secondary cervical dystonia

• Subject already been included in the study

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Idiopathic Cervical Dystonia
• Torticollis

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	St Vincent's Hospital	Fitzroy
Australia	Austin Hospital	Heidelberg
Australia	Westmead Hospital	Penrith
Australia	Alfred Hospital	Prahran
Belgium	AZ Sint Jan Brugge	Brugge
Belgium	UZ Gent	Gent
Belgium	Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen	Liege
Belgium	AZ Sint Augustinus Wilrijk	Wilrijk
Czechia	Fakultní nemocnice U Sv.Anny	Brno
Czechia	Fakultní nemocnice Olomouc	Olomouc
Czechia	Krajská nemocnice Pardubice	Pardubice
Czechia	Všeobecná fakultní nemocnice	Praha
France	Hôpital Neurologique et Neurochirurgical Pierre Wertheimer	Bron
France	Hôpital Roger Salengro	Lille
France	Hôpital La Timone	Marseille
France	Hôpital Pasteur - CHU Nice	Nice
France	Hôpital La Pitié Salpétrière	Paris
France	Hôpital Haut Lévêque	Pessac
France	Hôpital Purpan	Toulouse
Germany	Praxis für Neurologie	Berlin
Germany	Praxis für Neurologie	Bochum
Germany	Praxis für Neurologie, International Neuroscience Institute	Hannover
Germany	Praxis für Neurologie	Neusaß
Germany	Praxis für Neurologie und Psychatrie	Schorndorf
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Netherlands	Martini Ziekenhuis Groningen	Groningen
Netherlands	Tergooiziekenhuizen Hilversum	Hilversum
Portugal	Hospital Santa Maria	Lisboa
Portugal	Hospital General San Antonio - Centro Hospitalar do Porto	Porto
Portugal	Serviço de Neurologia - Hospital de São João	Porto
Russian Federation	16, ulitsa Vorovskogo	Chelyabinsk
Russian Federation	12a, ulitsa Karbyisheva	Kazan
Russian Federation	80, Volokolamskoye shossee	Moscow
Russian Federation	6/8, ulitsa L'va Tolstogo	St-Petersburg
United Kingdom	Royal Devon & Exeter Hospital	Exeter
United Kingdom	National Hospital for Neurology & Neurosurgery	London
United Kingdom	Walton Centre for Neurology & Neurosurgery, Hope Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Australia,  Belgium,  Czechia,  France,  Germany,  Netherlands,  Portugal,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice		Around 4 weeks post injection
Secondary	To describe TWSTRS change scores from inclusion (total score & subscales scores)		Baseline, and around 4 weeks and 3 months post injection
Secondary	To describe tremor change score from inclusion (TSUI scale)		Baseline, and around 4 weeks and 3 months post injection
Secondary	To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion		Baseline, and around 4 weeks post injection
Secondary	To describe subject and investigator's CGI scores		Around 4 weeks post injection
Secondary	To identify prognostic factors for response (Exploratory Objective)		baseline, and around 4 weeks and 3 months post injection