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

NCT ID: NCT00833196

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

404 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Cervical Dystonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Royal Prince Alfred Hospital

Camperdown, , Australia

Site Status

St Vincent's Hospital

Fitzroy, , Australia

Site Status

Austin Hospital

Heidelberg, , Australia

Site Status

Westmead Hospital

Penrith, , Australia

Site Status

Alfred Hospital

Prahran, , Australia

Site Status

AZ Sint Jan Brugge

Bruges, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Leuven, , Belgium

Site Status

Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen

Liège, , Belgium

Site Status

AZ Sint Augustinus Wilrijk

Wilrijk, , Belgium

Site Status

Fakultní nemocnice U Sv.Anny

Brno, , Czechia

Site Status

Fakultní nemocnice Olomouc

Olomouc, , Czechia

Site Status

Krajská nemocnice Pardubice

Pardubice, , Czechia

Site Status

Všeobecná fakultní nemocnice

Prague, , Czechia

Site Status

Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

Bron, , France

Site Status

Hôpital Roger Salengro

Lille, , France

Site Status

Hôpital La Timone

Marseille, , France

Site Status

Hôpital Pasteur - CHU Nice

Nice, , France

Site Status

Hôpital La Pitié Salpétrière

Paris, , France

Site Status

Hôpital Haut Lévêque

Pessac, , France

Site Status

Hôpital Purpan

Toulouse, , France

Site Status

Praxis für Neurologie

Berlin, , Germany

Site Status

Praxis für Neurologie

Bochum, , Germany

Site Status

Praxis für Neurologie, International Neuroscience Institute

Hanover, , Germany

Site Status

Praxis für Neurologie

Neusaß, , Germany

Site Status

Praxis für Neurologie und Psychatrie

Schorndorf, , Germany

Site Status

Krankenhaus der Barmherzigen Brüder

Trier, , Germany

Site Status

Martini Ziekenhuis Groningen

Groningen, , Netherlands

Site Status

Tergooiziekenhuizen Hilversum

Hilversum, , Netherlands

Site Status

Hospital Santa Maria

Lisbon, , Portugal

Site Status

Hospital General San Antonio - Centro Hospitalar do Porto

Porto, , Portugal

Site Status

Serviço de Neurologia - Hospital de São João

Porto, , Portugal

Site Status

16, ulitsa Vorovskogo

Chelyabinsk, , Russia

Site Status

12a, ulitsa Karbyisheva

Kazan', , Russia

Site Status

80, Volokolamskoye shossee

Moscow, , Russia

Site Status

6/8, ulitsa L'va Tolstogo

Saint Petersburg, , Russia

Site Status

Royal Devon & Exeter Hospital

Exeter, , United Kingdom

Site Status

National Hospital for Neurology & Neurosurgery

London, , United Kingdom

Site Status

Walton Centre for Neurology & Neurosurgery, Hope Hospital

Manchester, , United Kingdom

Site Status

Countries

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Australia Belgium Czechia France Germany Netherlands Portugal Russia United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34316644 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22700836 (View on PubMed)

Other Identifiers

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Y-79-52120-131

Identifier Type: -

Identifier Source: org_study_id

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