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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - Botulinum toxin type A

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


Other interventions: Botulinum toxin type A
Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.
Intervention code [1] 0 0
Other interventions
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
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United States of America
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Tennessee
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Algeria
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Alger
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Algeria
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Constantine
Country [7] 0 0
Austria
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Vienna
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Belgium
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Brugge
Country [9] 0 0
Belgium
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Edegem
Country [10] 0 0
Belgium
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Gent
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Belgium
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Liège
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Brazil
State/province [12] 0 0
Belo Horizonte
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Brazil
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Ribeirão Preto
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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China
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Hong Kong
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Czechia
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Brno
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Czechia
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Olomouc
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Czechia
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Pardubice
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Czechia
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Prague
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Estonia
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Tallinn
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Estonia
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Tartu
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France
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Albi
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France
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Amiens Cedex 1
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France
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Aulnay/sous Bois cedex
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France
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Bron Cedex
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France
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Lille cedex
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France
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Marseille Cedex
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France
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Nimes cedex 09
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France
State/province [30] 0 0
Toulouse Cedex 9
Country [31] 0 0
Germany
State/province [31] 0 0
Erlangen
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Germany
State/province [32] 0 0
Hannover
Country [33] 0 0
Germany
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Karlsruhe
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Germany
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Neusaß
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Germany
State/province [35] 0 0
Tübingen
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Germany
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Würzburg
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Hungary
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Budapest
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Hungary
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Nyíregyháza
Country [39] 0 0
Israel
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Haifa
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Israel
State/province [40] 0 0
Ramat Gan
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Israel
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Tel-Aviv
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Italy
State/province [42] 0 0
Bergamo
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Italy
State/province [43] 0 0
Ferrara
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Italy
State/province [44] 0 0
Messina
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Italy
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Napoli
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Italy
State/province [46] 0 0
Palermo
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Italy
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Roma
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Italy
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Torino
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Jordan
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Amman
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Yangsan
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Latvia
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Jurmala
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Latvia
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Riga
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Lebanon
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Beirut
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Lebanon
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Jbaïl
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Malaysia
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Kuala Lumpur
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Nuevo Leon
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Durango
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Quezon
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Katowice
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Warsaw
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Portugal
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Lisbon
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Portugal
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Porto
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Portugal
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Setùbal
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Portugal
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Vila Real
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Romania
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Bucuresti
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Romania
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Timisoara
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Russian Federation
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Chelyabinsk
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Kazan
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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St-Peterburg
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Serbia
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Belgrade
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Singapore
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Singapore
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Slovenia
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Ljubljana
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Slovenia
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Maribor
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Sweden
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Helsingborg
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Sweden
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Linköping
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Sweden
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Malmö
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Sweden
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Stockholm
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Sweden
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Umeå
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
State/province [91] 0 0
Bangkok
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Mersin
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United Arab Emirates
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Dubai
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United Kingdom
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Exeter
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United Kingdom
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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
The purpose of the study is to document long-term response in real-life practice after
injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia
(Long-term clinical and pharmaco-economic data).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01753349
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