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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00833196
Ethics application status
Date submitted
29/01/2009
Date registered
29/01/2009
Date last updated
10/01/2019

Titles & IDs
Public title
Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
Scientific title
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
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
Primary outcome [2] 0 0
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Timepoint [2] 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
Secondary outcome [6] 0 0
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Timepoint [6] 0 0
Baseline, and around 4 weeks and 3 months post injection
Secondary outcome [7] 0 0
To describe tremor change score from inclusion (TSUI scale)
Timepoint [7] 0 0
Baseline, and around 4 weeks and 3 months post injection
Secondary outcome [8] 0 0
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Timepoint [8] 0 0
Baseline, and around 4 weeks post injection
Secondary outcome [9] 0 0
To describe subject and investigator's CGI scores
Timepoint [9] 0 0
Around 4 weeks post injection
Secondary outcome [10] 0 0
To identify prognostic factors for response (Exploratory Objective)
Timepoint [10] 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 - Heidelburg
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 - Heidelburg
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
Neusaess
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/show/NCT00833196
Trial related presentations / publications
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
Other publications