Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
1 other identifier
observational
404
9 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
39 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
First Submitted
Initial submission to the registry
January 29, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 16, 2019
August 1, 2019
1 year
January 29, 2009
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Around 4 weeks post injection
Secondary Outcomes (5)
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Baseline, and around 4 weeks and 3 months post injection
To describe tremor change score from inclusion (TSUI scale)
Baseline, and around 4 weeks and 3 months post injection
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Baseline, and around 4 weeks post injection
To describe subject and investigator's CGI scores
Around 4 weeks post injection
To identify prognostic factors for response (Exploratory Objective)
baseline, and around 4 weeks and 3 months post injection
Eligibility Criteria
Patients with idiopathic cervical dystonia
You may qualify if:
- Idiopathic cervical dystonia
- TWSTRS severity score ≥ 15
- Written informed consent prior to collect the data
You may not qualify if:
- Contraindications to any BoNT-A preparations
- Secondary cervical dystonia
- Subject already been included in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (39)
Royal Prince Alfred Hospital
Camperdown, NSW 2050, Australia
St Vincent's Hospital
Fitzroy, VIC 3065, Australia
Austin Hospital
Heidelberg, VIC 3084, Australia
Westmead Hospital
Penrith, NSW 2751, Australia
Alfred Hospital
Prahran, VIC 3181, Australia
AZ Sint Jan Brugge
Bruges, 8000, Belgium
UZ Gent
Ghent, 9000, Belgium
Unknown Facility
Leuven, 3000, Belgium
Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen
Liège, B 4000, Belgium
AZ Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Fakultní nemocnice U Sv.Anny
Brno, 656 91 Brno, Czechia
Fakultní nemocnice Olomouc
Olomouc, 775 20 Olomouc, Czechia
Krajská nemocnice Pardubice
Pardubice, 530 03 Pardubice, Czechia
Všeobecná fakultní nemocnice
Prague, 120 00 Praha 2, Czechia
Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
Bron, 69677, France
Hôpital Roger Salengro
Lille, 59037, France
Hôpital La Timone
Marseille, 13385, France
Hôpital Pasteur - CHU Nice
Nice, 06002, France
Hôpital La Pitié Salpétrière
Paris, 75651, France
Hôpital Haut Lévêque
Pessac, 33604, France
Hôpital Purpan
Toulouse, 31059, France
Praxis für Neurologie
Berlin, 10178, Germany
Praxis für Neurologie
Bochum, 44787, Germany
Praxis für Neurologie, International Neuroscience Institute
Hanover, 30625, Germany
Praxis für Neurologie
Neusaß, 86356, Germany
Praxis für Neurologie und Psychatrie
Schorndorf, 73614, Germany
Krankenhaus der Barmherzigen Brüder
Trier, 54929, Germany
Martini Ziekenhuis Groningen
Groningen, 9728 - NZ, Netherlands
Tergooiziekenhuizen Hilversum
Hilversum, 1213 - XZ, Netherlands
Hospital Santa Maria
Lisbon, 1649-035, Portugal
Hospital General San Antonio - Centro Hospitalar do Porto
Porto, 4099-001, Portugal
Serviço de Neurologia - Hospital de São João
Porto, 4202-451, Portugal
16, ulitsa Vorovskogo
Chelyabinsk, 454048, Russia
12a, ulitsa Karbyisheva
Kazan', 420101, Russia
80, Volokolamskoye shossee
Moscow, 123367, Russia
6/8, ulitsa L'va Tolstogo
Saint Petersburg, 197022, Russia
Royal Devon & Exeter Hospital
Exeter, EX2 5DW, United Kingdom
National Hospital for Neurology & Neurosurgery
London, WC1N 3BG, United Kingdom
Walton Centre for Neurology & Neurosurgery, Hope Hospital
Manchester, M6 8HP, United Kingdom
Related Publications (2)
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.
PMID: 34316644DERIVEDMisra 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.
PMID: 22700836DERIVED
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2009
First Posted
January 30, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2010
Study Completion
April 1, 2010
Last Updated
August 16, 2019
Record last verified: 2019-08