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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00833196




Registration number
NCT00833196
Ethics application status
Date submitted
29/01/2009
Date registered
30/01/2009
Date last updated
16/08/2019

Titles & IDs
Public title
Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
Scientific title
An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
Secondary ID [1] 0 0
Y-79-52120-131
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Cervical Dystonia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Timepoint [1] 0 0
Around 4 weeks post injection
Secondary outcome [1] 0 0
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Timepoint [1] 0 0
Baseline, and around 4 weeks and 3 months post injection
Secondary outcome [2] 0 0
To describe tremor change score from inclusion (TSUI scale)
Timepoint [2] 0 0
Baseline, and around 4 weeks and 3 months post injection
Secondary outcome [3] 0 0
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Timepoint [3] 0 0
Baseline, and around 4 weeks post injection
Secondary outcome [4] 0 0
To describe subject and investigator's CGI scores
Timepoint [4] 0 0
Around 4 weeks post injection
Secondary outcome [5] 0 0
To identify prognostic factors for response (Exploratory Objective)
Timepoint [5] 0 0
baseline, and around 4 weeks and 3 months post injection

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications to any BoNT-A preparations
* Secondary cervical dystonia
* Subject already been included in the study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
404
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Westmead Hospital - Penrith
Recruitment hospital [5] 0 0
Alfred Hospital - Prahran
Recruitment postcode(s) [1] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [2] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
NSW 2751 - Penrith
Recruitment postcode(s) [5] 0 0
VIC 3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brugge
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Liege
Country [5] 0 0
Belgium
State/province [5] 0 0
Wilrijk
Country [6] 0 0
Czechia
State/province [6] 0 0
Brno
Country [7] 0 0
Czechia
State/province [7] 0 0
Olomouc
Country [8] 0 0
Czechia
State/province [8] 0 0
Pardubice
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha
Country [10] 0 0
France
State/province [10] 0 0
Bron
Country [11] 0 0
France
State/province [11] 0 0
Lille
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Nice
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Pessac
Country [16] 0 0
France
State/province [16] 0 0
Toulouse
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Bochum
Country [19] 0 0
Germany
State/province [19] 0 0
Hannover
Country [20] 0 0
Germany
State/province [20] 0 0
Neusaß
Country [21] 0 0
Germany
State/province [21] 0 0
Schorndorf
Country [22] 0 0
Germany
State/province [22] 0 0
Trier
Country [23] 0 0
Netherlands
State/province [23] 0 0
Groningen
Country [24] 0 0
Netherlands
State/province [24] 0 0
Hilversum
Country [25] 0 0
Portugal
State/province [25] 0 0
Lisboa
Country [26] 0 0
Portugal
State/province [26] 0 0
Porto
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Chelyabinsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Kazan
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
St-Petersburg
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Exeter
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00833196
Trial related presentations / publications
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.
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. Erratum In: BMJ Open. 2013 May 31;3(5):e000881corr1. doi: 10.1136/bmjopen-2012-000881corr1.
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00833196