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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01753349




Registration number
NCT01753349
Ethics application status
Date submitted
17/12/2012
Date registered
20/12/2012
Date last updated
5/11/2020

Titles & IDs
Public title
Phase IV-Cervical Dystonia-INTEREST IN CD2
Scientific title
An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact
Secondary ID [1] 0 0
Y-79-52120-166
Universal Trial Number (UTN)
Trial acronym
INTEREST_INCD2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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
Treatment: Other - Botulinum toxin type A

Idiopathic cervical dystonia - Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly.


Treatment: Other: Botulinum toxin type A
Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in subject's satisfaction using a 5-point Likert scale.
Timepoint [1] 0 0
Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcome [1] 0 0
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.
Timepoint [1] 0 0
Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcome [2] 0 0
Change in tremor associated with CD using Tsui score
Timepoint [2] 0 0
Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcome [3] 0 0
Change in pain relief assessed using the TWSTRS pain sub-scale.
Timepoint [3] 0 0
Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcome [4] 0 0
Change in disability will be measured with the TWSTRS disability sub-scale.
Timepoint [4] 0 0
Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcome [5] 0 0
Pharmaco-economic endpoints
Timepoint [5] 0 0
Baseline and at every 3 to 4 months, up to 3 years.

Eligibility
Key inclusion criteria
* Subject for whom there is an intention to treat with BoNT-A.
* BoNT treatment naïve or previously treated with BoNT.
* If previously treated with BoNT, at least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion.
* Subject able to comply with the protocol.
* Provision of 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.
* The subject has 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
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/09/2017
Sample size
Target
Accrual to date
Final
1050
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Alfred Hospital, - Melbourne
Recruitment hospital [3] 0 0
Dandenong Neurology - Melbourne
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [5] 0 0
Burwest Neurophysiology - Sydney
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
30004 - Melbourne
Recruitment postcode(s) [3] 0 0
3175 - Melbourne
Recruitment postcode(s) [4] 0 0
2065 - Sydney
Recruitment postcode(s) [5] 0 0
2134 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Algeria
State/province [5] 0 0
Alger
Country [6] 0 0
Algeria
State/province [6] 0 0
Constantine
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Belgium
State/province [8] 0 0
Brugge
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Brazil
State/province [12] 0 0
Belo Horizonte
Country [13] 0 0
Brazil
State/province [13] 0 0
Ribeirão Preto
Country [14] 0 0
Brazil
State/province [14] 0 0
Rio De Janeiro
Country [15] 0 0
Brazil
State/province [15] 0 0
Sao Paulo
Country [16] 0 0
China
State/province [16] 0 0
Hong Kong
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czechia
State/province [19] 0 0
Pardubice
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague
Country [21] 0 0
Estonia
State/province [21] 0 0
Tallinn
Country [22] 0 0
Estonia
State/province [22] 0 0
Tartu
Country [23] 0 0
France
State/province [23] 0 0
Albi
Country [24] 0 0
France
State/province [24] 0 0
Amiens Cedex 1
Country [25] 0 0
France
State/province [25] 0 0
Aulnay/sous Bois cedex
Country [26] 0 0
France
State/province [26] 0 0
Bron Cedex
Country [27] 0 0
France
State/province [27] 0 0
Lille cedex
Country [28] 0 0
France
State/province [28] 0 0
Marseille Cedex
Country [29] 0 0
France
State/province [29] 0 0
Nimes cedex 09
Country [30] 0 0
France
State/province [30] 0 0
Toulouse Cedex 9
Country [31] 0 0
Germany
State/province [31] 0 0
Erlangen
Country [32] 0 0
Germany
State/province [32] 0 0
Hannover
Country [33] 0 0
Germany
State/province [33] 0 0
Karlsruhe
Country [34] 0 0
Germany
State/province [34] 0 0
Neusaß
Country [35] 0 0
Germany
State/province [35] 0 0
Tübingen
Country [36] 0 0
Germany
State/province [36] 0 0
Würzburg
Country [37] 0 0
Hungary
State/province [37] 0 0
Budapest
Country [38] 0 0
Hungary
State/province [38] 0 0
Nyíregyháza
Country [39] 0 0
Israel
State/province [39] 0 0
Haifa
Country [40] 0 0
Israel
State/province [40] 0 0
Ramat Gan
Country [41] 0 0
Israel
State/province [41] 0 0
Tel-Aviv
Country [42] 0 0
Italy
State/province [42] 0 0
Bergamo
Country [43] 0 0
Italy
State/province [43] 0 0
Ferrara
Country [44] 0 0
Italy
State/province [44] 0 0
Messina
Country [45] 0 0
Italy
State/province [45] 0 0
Napoli
Country [46] 0 0
Italy
State/province [46] 0 0
Palermo
Country [47] 0 0
Italy
State/province [47] 0 0
Roma
Country [48] 0 0
Italy
State/province [48] 0 0
Torino
Country [49] 0 0
Jordan
State/province [49] 0 0
Amman
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Busan
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Gyeonggi-Do
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Seoul
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Yangsan
Country [54] 0 0
Latvia
State/province [54] 0 0
Jurmala
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Latvia
State/province [55] 0 0
Riga
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Lebanon
State/province [56] 0 0
Beirut
Country [57] 0 0
Lebanon
State/province [57] 0 0
Jbaïl
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Malaysia
State/province [58] 0 0
Kuala Lumpur
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Mexico
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Nuevo Leon
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Mexico
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Durango
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Mexico
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Mexico City
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Mexico
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Querétaro
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Philippines
State/province [63] 0 0
Manila
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Philippines
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Quezon
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Poland
State/province [65] 0 0
Katowice
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Poland
State/province [66] 0 0
Warsaw
Country [67] 0 0
Portugal
State/province [67] 0 0
Lisbon
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Portugal
State/province [68] 0 0
Porto
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Portugal
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Setùbal
Country [70] 0 0
Portugal
State/province [70] 0 0
Vila Real
Country [71] 0 0
Romania
State/province [71] 0 0
Bucuresti
Country [72] 0 0
Romania
State/province [72] 0 0
Timisoara
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
Country [75] 0 0
Russian Federation
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Krasnoyarsk
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Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
St-Peterburg
Country [78] 0 0
Serbia
State/province [78] 0 0
Belgrade
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
Slovenia
State/province [80] 0 0
Ljubljana
Country [81] 0 0
Slovenia
State/province [81] 0 0
Maribor
Country [82] 0 0
Sweden
State/province [82] 0 0
Helsingborg
Country [83] 0 0
Sweden
State/province [83] 0 0
Linköping
Country [84] 0 0
Sweden
State/province [84] 0 0
Malmö
Country [85] 0 0
Sweden
State/province [85] 0 0
Stockholm
Country [86] 0 0
Sweden
State/province [86] 0 0
Umeå
Country [87] 0 0
Sweden
State/province [87] 0 0
Uppsala
Country [88] 0 0
Taiwan
State/province [88] 0 0
Kaohsiung
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taichung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taipei
Country [91] 0 0
Thailand
State/province [91] 0 0
Bangkok
Country [92] 0 0
Turkey
State/province [92] 0 0
Ankara
Country [93] 0 0
Turkey
State/province [93] 0 0
Istanbul
Country [94] 0 0
Turkey
State/province [94] 0 0
Mersin
Country [95] 0 0
United Arab Emirates
State/province [95] 0 0
Dubai
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Exeter
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Leeds
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Oxford
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Romford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01753349