Cervical DystoniaINTEREST_INCD2NCT01753349
Phase IV-Cervical Dystonia-INTEREST IN CD2
An observational study of Cervical Dystonia, run by Ipsen at 113 sites in 34 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- How many people
- 1,050 participants
- Where
- 113 sitesin 34 countries
- Study dates
- Dec 2012to 25 Sep 2017
- 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: Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.
Who may be able to join
- 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.
Who cannot join
- Contraindications to any BoNT-A preparations.
- The subject has already been included in the study.
Trial locations and contacts
113 sites in 34 countries.
113 sites in 34 countries
France8 sites
Centre Hospitalier d'Albi
Albi, 81000
CHU Amiens Nord
Amiens, 80054
CHI Robert Ballanger
Aulnay-sous-Bois, 93602
CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer
Bron, 69677
Hôpital Roger Salengro
Lille, 59037
Hôpital La Timone
Marseille, 13385
Hopital universitaire Carémeau
Nîmes, 30029
Hôpital Purpan
Toulouse, 31059
Italy8 sites
Ospedali Riuniti di Bergamo
Bergamo, 24100
Azienda Ospedaliera-Universitaria
Ferrara, 44100
A.O.U. Policlinico "G. Martino
Messina, 98125
II Università degli Studi di Napoli
Naples, 80131
A.O. Villa Sofia CTO
Palermo, 90144
Policlinico Umberto I, Università La Sapienza
Roma, 00185
Università La Sapienza
Roma, 00185
Ospedale Mauriziano - Umberto I
Torino, 10128
Germany6 sites
Neurologische Universitätsklinik Erlangen
Erlangen, 91054
Neurologische Privatpraxis
Hanover, 30627
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Hauptstraße 1a
Neusaß, 86356
Universitätsklinikum Tübingen
Tübingen, 72076
Universitätsklinikum Würzburg
Würzburg, 97080
Mexico6 sites
Hospital General Dr. Santiago Ramón y Cajal
Durango, 34070
Hospital General de México
Mexico City, 06720
Nuevo Hospital Obregón
Mexico City, 15740
Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"
Mexico City
Centro de Rehabilitación Integral de Querétaro
Querétaro, 76090
Centro Medico Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278
Sweden6 sites
Stortorgets Neurologmottagning
Helsingborg, 252 20
Universtitessjukhuset i Linköping
Linköping, 582 85
Skånes University Hospital
Malmö, 205 02
Neuroenheten Utsikten
Stockholm, 116 28
Norrlands Universitetssjukhus (NUS)
Umeå, 901 85
Uppsala University Hospital
Uppsala, 751 85
Australia5 sites
Austin Hospital
Heidelberg, Victoria, 3084
Alfred Hospital,
Melbourne, 30004
Dandenong Neurology
Melbourne, 3175
Royal North Shore Hospital
Sydney, 2065
Burwest Neurophysiology
Sydney, 2134
Russia5 sites
The Chelyabinsk state medical academy,
Chelyabinsk, 454092
State Institution "Interregional clinical diagnostic centre"
Kazan', 420101
State Educational Institution of high professional education "Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky of the Ministry of Health and Social Development of Russia"
Krasnoyarsk, 660022
State Federal Budgetary Institution Scientific Center of Neurology RAMS
Moscow, 125367
State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"
St-Peterburg, 197022
South Korea5 sites
Dong-A University Hospital
Busan, 602-715
Seoul National University Bundang Hospital
Gyeonggi-do
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan
United States4 sites
Tufts Medical Center, Inc
Boston, Massachusetts, 02111
Parkinson's and Movement Disorders Center of Maryland
Elkridge, Maryland, 21075
Vanderbilt University
Nashville, Tennessee, 37232
The Parkinson's and Movement Disorders Center
Southfield, Michigan, 48034
Belgium4 sites
AZ Sint Jan Brugge - Oostende AV
Bruges, 8000
Universitair Ziekenhuis Antwerpen
Edegem, 2650
AZ Sint Lucas
Ghent, 9000
Centre Hospitalier Universitaire de Liège
Liège, 4000
Brazil4 sites
Hospital das Clínicas, Universidade Federal de Minas Gerais
Belo Horizonte, 30130-100
Campus Universitario
Ribeirão Preto, 14048-900
Hospital Universitario Antoni Pedro
Rio de Janeiro, 24033-900
Instituto de Medicina Física e Reabilitaçao
São Paulo, 04116-030
Czechia4 sites
Faculty Hospital Sv. Anna Brno
Brno
Faculty hospital Olomouc
Olomouc, 775 20
Pardubice Regional Hospital, Inc.
Pardubice, 532 03
Department of Neurology 1st LF UK and VFN
Prague, 128 21
Portugal4 sites
Centro Hospitalar Lisboa Norte
Lisbon, 1649-035
Centro Hospitalar do Porto
Porto, 4099-001
Hospital São Bernardo
Setùbal, 2910-446
Centro Hospitalar de Trás-os-Montes e Alto Douro
Vila Real, 5000-508
Turkey (Türkiye)4 sites
Gazi University Medical Faculty
Ankara
Hacettepe University Medical Faculty
Ankara
Istanbul University Cerrahpaşa Medical Faculty
Istanbul
Dogu Mersin University Hospital
Mersin
United Kingdom4 sites
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
Leeds General Infirmary
Leeds, LS1 3EX
Neurology, John Radcliffe Hospital
Oxford, OX3 9DU
Queen's Hospital Romford
Romford, RM7 0AG
Algeria3 sites
Bab El Oued Hospital
Algiers, 16009
Sidi Bel Abbes Hospital
Algiers, 22000
Ben Badis Hospital
Constantine, 25000
Israel3 sites
Carmel Medical Center Haifa Israël
Haifa, 34361
Sheba Medical Center
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Taiwan3 sites
Kaohsiung Chang-gung Memorial Hospital
Kaohsiung City
TaiChung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Estonia2 sites
East Tallinn Central Hospital
Tallinn, 10138
Tartu University Hospital, Neurology Clinic
Tartu, 51014
Hungary2 sites
Semmelweis Egyetem
Budapest, 1083
Jósa András Oktató Kórház
Nyíregyháza, 4400
Latvia2 sites
National Rehabilitation center "Vaivari"
Jūrmala, 2008,
P. Stradins Clinical University hospital
Riga, 1002
Lebanon2 sites
Hopital Hotel Dieu
Beirut
Centre Hospitalier Universitaire Notre Dame de Secours
Byblos
Malaysia2 sites
Hospital Kuala Lumpur
Kuala Lumpur, 50586
University of Malaysia
Kuala Lumpur, 50603
Philippines2 sites
Metropolitan Medical Center
Manila
St Luke's Medical Center
Quezon
Poland2 sites
Specjalistyczna Praktyka Lekarska
Katowice, 40-097
Medical University of Warsaw
Warsaw, 02-097
Romania2 sites
Spitalul Universitar de Urgenta Bucuresti, neurologie
Bucharest, Sector 5050098
Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II
Timișoara, 300736
Serbia2 sites
Clinical Center of Serbia
Belgrade, 11000
Military Medical Academy
Belgrade, 11000
Slovenia2 sites
University Medical Centre Ljubljana
Ljubljana, 1000
University Clinical Centre Maribor
Maribor
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok
Siriraj Hospital
Bangkok
About this study
Official 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
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).
- Conditions
- Cervical Dystonia
- Being tested
- Botulinum toxin type A
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic cervical dystonia | Adults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly. Receives: Biological: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subject's satisfaction using a 5-point Likert scale.
Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.
Measured: Baseline and at every 3 to 4 months, up to 3 years.
Secondary outcomes (5)
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.
Assessment of severity of CD.
Measured: Baseline and at every 3 to 4 months, up to 3 years.
Change in tremor associated with CD using Tsui score
Measured: Baseline and at every 3 to 4 months, up to 3 years.
Change in pain relief assessed using the TWSTRS pain sub-scale.
Measured: Baseline and at every 3 to 4 months, up to 3 years.
Change in disability will be measured with the TWSTRS disability sub-scale.
Measured: Baseline and at every 3 to 4 months, up to 3 years.
Pharmaco-economic endpoints
- Time intervals between injections
- Changes in concomitant treatments for CD and associated symptoms.
- Changes in employment status
Measured: Baseline and at every 3 to 4 months, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2017
- Study completion25 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 1,050 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
- NCT01753349
- Sponsor's protocol ID
- Y-79-52120-166
- Acronym
- INTEREST_INCD2
- Status last verified
- Nov 2020
- First submitted
- 17 Dec 2012
- Last updated
- 5 Nov 2020
- 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 34316644
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01753349
- Acronym / sponsor ID
- INTEREST_INCD2 / Y-79-52120-166
- Conditions
- Cervical Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 25 Sep 2017 (actual)
- First posted
- 20 Dec 2012 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic cervical dystonia | – | Biological: Botulinum toxin type AAdults subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia. BoNT-A injections, 3-4 times yearly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects from Hospitals, Private Practices suffering idiopathic cervical dystonia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to any BoNT-A preparations.
- The subject has 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AInvestigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin. | Biological | Idiopathic cervical dystonia |
Primary outcome
Change in subject's satisfaction using a 5-point Likert scale.
Time frame: Baseline and at every 3 to 4 months, up to 3 years.
Identification of prognostic factors for subject's satisfaction regarding control of symptoms associated with idiopathic CD.
5 secondary outcomes
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale.
Time frame: Baseline and at every 3 to 4 months, up to 3 years.
Change in tremor associated with CD using Tsui score
Time frame: Baseline and at every 3 to 4 months, up to 3 years.
Change in pain relief assessed using the TWSTRS pain sub-scale.
Time frame: Baseline and at every 3 to 4 months, up to 3 years.
Change in disability will be measured with the TWSTRS disability sub-scale.
Time frame: Baseline and at every 3 to 4 months, up to 3 years.
Pharmaco-economic endpoints
Time frame: Baseline and at every 3 to 4 months, up to 3 years.
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 5 Nov 2020.
- 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.
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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
113 sites in 34 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dystonia, run by Ipsen at 113 sites in 34 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 5 inclusion and 2 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in France, Italy, Germany, Mexico, Sweden and 29 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?
Change in subject's satisfaction using a 5-point Likert scale. (time frame: Baseline and at every 3 to 4 months, up to 3 years.). 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 NCT01753349, which also lists 1 linked publication.
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 5 Nov 2020.