Idiopathic Cervical DystoniaNCT00833196
Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
An observational study of Idiopathic Cervical Dystonia, run by Ipsen at 39 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Cervical Dystonia
- How many people
- 404 participants
- Where
- 39 sitesin 9 countries
- Study dates
- Feb 2009to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with idiopathic cervical dystonia
Who may be able to join
- 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
Who cannot join
- Contraindications to any BoNT-A preparations
- Secondary cervical dystonia
- Subject already been included in the study
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
France7 sites
Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
Bron, 69677
Hôpital Roger Salengro
Lille, 59037
Hôpital La Timone
Marseille, 13385
Hôpital Pasteur - CHU Nice
Nice, 06002
Hôpital La Pitié Salpétrière
Paris, 75651
Hôpital Haut Lévêque
Pessac, 33604
Hôpital Purpan
Toulouse, 31059
Germany6 sites
Praxis für Neurologie
Berlin, 10178
Praxis für Neurologie
Bochum, 44787
Praxis für Neurologie, International Neuroscience Institute
Hanover, 30625
Praxis für Neurologie
Neusaß, 86356
Praxis für Neurologie und Psychatrie
Schorndorf, 73614
Krankenhaus der Barmherzigen Brüder
Trier, 54929
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, NSW 2050
St Vincent's Hospital
Fitzroy, VIC 3065
Austin Hospital
Heidelberg, VIC 3084
Westmead Hospital
Penrith, NSW 2751
Alfred Hospital
Prahran, VIC 3181
Belgium5 sites
AZ Sint Jan Brugge
Bruges, 8000
UZ Gent
Ghent, 9000
Study site
Leuven, 3000
Centre Hospitalier de Liège, Domaine Universitaire Sart Tilmen
Liège, B 4000
AZ Sint Augustinus Wilrijk
Wilrijk, 2610
Czechia4 sites
Fakultní nemocnice U Sv.Anny
Brno, 656 91 Brno
Fakultní nemocnice Olomouc
Olomouc, 775 20 Olomouc
Krajská nemocnice Pardubice
Pardubice, 530 03 Pardubice
Všeobecná fakultní nemocnice
Prague, 120 00 Praha 2
Russia4 sites
16, ulitsa Vorovskogo
Chelyabinsk, 454048
12a, ulitsa Karbyisheva
Kazan', 420101
80, Volokolamskoye shossee
Moscow, 123367
6/8, ulitsa L'va Tolstogo
Saint Petersburg, 197022
Portugal3 sites
Hospital Santa Maria
Lisbon, 1649-035
Hospital General San Antonio - Centro Hospitalar do Porto
Porto, 4099-001
Serviço de Neurologia - Hospital de São João
Porto, 4202-451
United Kingdom3 sites
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
National Hospital for Neurology & Neurosurgery
London, WC1N 3BG
Walton Centre for Neurology & Neurosurgery, Hope Hospital
Manchester, M6 8HP
Netherlands2 sites
Martini Ziekenhuis Groningen
Groningen, 9728 - NZ
Tergooiziekenhuizen Hilversum
Hilversum, 1213 - XZ
About this study
Official title: An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
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.
- Conditions
- Idiopathic Cervical Dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Measured: Around 4 weeks post injection
Secondary outcomes (5)
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Measured: Baseline, and around 4 weeks and 3 months post injection
To describe tremor change score from inclusion (TSUI scale)
Measured: Baseline, and around 4 weeks and 3 months post injection
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Measured: Baseline, and around 4 weeks post injection
To describe subject and investigator's CGI scores
Measured: Around 4 weeks post injection
To identify prognostic factors for response (Exploratory Objective)
Measured: baseline, and around 4 weeks and 3 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833196
- Sponsor's protocol ID
- Y-79-52120-131
- Status last verified
- Aug 2019
- First submitted
- 29 Jan 2009
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34316644Misra 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.
PubMed 22700836
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Observational Study to Define Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
- ClinicalTrials.gov ID
- NCT00833196
- Acronym / sponsor ID
- Y-79-52120-131
- Conditions
- Idiopathic Cervical Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with idiopathic cervical dystonia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindications to any BoNT-A preparations
- Secondary cervical dystonia
- Subject already been included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice
Time frame: Around 4 weeks post injection
5 secondary outcomes
To describe TWSTRS change scores from inclusion (total score & subscales scores)
Time frame: Baseline, and around 4 weeks and 3 months post injection
To describe tremor change score from inclusion (TSUI scale)
Time frame: Baseline, and around 4 weeks and 3 months post injection
To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion
Time frame: Baseline, and around 4 weeks post injection
To describe subject and investigator's CGI scores
Time frame: Around 4 weeks post injection
To identify prognostic factors for response (Exploratory Objective)
Time frame: baseline, and around 4 weeks and 3 months post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 34316644Trosch 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.
- Derived from this study: PubMed 22700836Misra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Cervical Dystonia, run by Ipsen at 39 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France, Germany, Australia, Belgium, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice (time frame: Around 4 weeks post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.