Clinical trial NCT00833196: Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
Official title: An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic cervical dystonia

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
timeFrame: Around 4 weeks post injection
Secondary outcomes:
measure: To describe TWSTRS change scores from inclusion (total score & subscales scores)
timeFrame: Baseline, and around 4 weeks and 3 months post injection
measure: To describe tremor change score from inclusion (TSUI scale)
timeFrame: Baseline, and around 4 weeks and 3 months post injection
measure: To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
timeFrame: Baseline, and around 4 weeks post injection
measure: To describe subject and investigator's CGI scores
timeFrame: Around 4 weeks post injection
measure: To identify prognostic factors for response (Exploratory Objective)
timeFrame: baseline, and around 4 weeks and 3 months post injection
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Penrith
country: Australia
facility: Westmead Hospital
city: Prahran
country: Australia
facility: Alfred Hospital
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
city: Liege
country: Belgium
facility: Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen
city: Wilrijk
country: Belgium
facility: AZ Sint Augustinus Wilrijk
city: Brno
country: Czechia
facility: Fakultní nemocnice U Sv.Anny
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Pardubice
country: Czechia
facility: Krajská nemocnice Pardubice
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice
city: Bron
country: France
facility: Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Marseille
country: France
facility: Hôpital La Timone
city: Nice
country: France
facility: Hôpital Pasteur - CHU Nice
city: Paris
country: France
facility: Hôpital La Pitié Salpétrière
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Toulouse
country: France
facility: Hôpital Purpan
city: Berlin
country: Germany
facility: Praxis für Neurologie
city: Bochum
country: Germany
facility: Praxis für Neurologie
city: Hannover
country: Germany
facility: Praxis für Neurologie, International Neuroscience Institute
city: Neusaß
country: Germany
facility: Praxis für Neurologie
city: Schorndorf
country: Germany
facility: Praxis für Neurologie und Psychatrie
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis Groningen
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen Hilversum
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Porto
country: Portugal
facility: Hospital General San Antonio - Centro Hospitalar do Porto
city: Porto
country: Portugal
facility: Serviço de Neurologia - Hospital de São João
city: Chelyabinsk
country: Russian Federation
facility: 16, ulitsa Vorovskogo
city: Kazan
country: Russian Federation
facility: 12a, ulitsa Karbyisheva
city: Moscow
country: Russian Federation
facility: 80, Volokolamskoye shossee
city: St-Petersburg
country: Russian Federation
facility: 6/8, ulitsa L'va Tolstogo
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: London
country: United Kingdom
facility: National Hospital for Neurology & Neurosurgery
city: Manchester
country: United Kingdom
facility: Walton Centre for Neurology & Neurosurgery, Hope Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.
citation: Misra VP, Ehler E, Zakine B, Maisonobe P, Simonetta-Moreau M; INTEREST IN CD group. Factors influencing response to Botulinum toxin type A in patients with idiopathic cervical dystonia: results from an international observational study. BMJ Open. 2012 Jun 14;2(3):e000881. doi: 10.1136/bmjopen-2012-000881. Print 2012.