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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01753349
Other study ID # Y-79-52120-166
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2012
Est. completion date September 25, 2017

Study information

Verified date November 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


Recruitment information / eligibility

Status Completed
Enrollment 1050
Est. completion date September 25, 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: - Contraindications to any BoNT-A preparations. - The subject has already been included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Botulinum toxin type A
Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.

Locations

Country Name City State
Algeria Bab El Oued Hospital Alger
Algeria Sidi Bel Abbes Hospital Alger
Algeria Ben Badis Hospital Constantine
Australia Austin Hospital Heidelberg Victoria
Australia Alfred Hospital, Melbourne
Australia Dandenong Neurology Melbourne
Australia Burwest Neurophysiology Sydney
Australia Royal North Shore Hospital Sydney
Austria Medical University of Vienna Spitalgasse 23 Vienna
Belgium AZ Sint Jan Brugge - Oostende AV Brugge
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium AZ Sint Lucas Gent
Belgium Centre Hospitalier Universitaire de Liège Liège
Brazil Hospital das Clínicas, Universidade Federal de Minas Gerais Belo Horizonte
Brazil Campus Universitario Ribeirão Preto
Brazil Hospital Universitario Antoni Pedro Rio De Janeiro
Brazil Instituto de Medicina Física e Reabilitaçao Sao Paulo
China Queen Mary Hospital Hong Kong
Czechia Faculty Hospital Sv. Anna Brno Brno
Czechia Faculty hospital Olomouc Olomouc
Czechia Pardubice Regional Hospital, Inc. Pardubice
Czechia Department of Neurology 1st LF UK and VFN Prague
Estonia East Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital, Neurology Clinic Tartu
France Centre Hospitalier d'Albi Albi
France CHU Amiens Nord Amiens Cedex 1
France CHI Robert Ballanger Aulnay/sous Bois cedex
France CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer Bron Cedex
France Hôpital Roger Salengro Lille cedex
France Hôpital La Timone Marseille Cedex
France Hopital universitaire Carémeau Nimes cedex 09
France Hôpital Purpan Toulouse Cedex 9
Germany Neurologische Universitätsklinik Erlangen Erlangen
Germany Neurologische Privatpraxis Hannover
Germany Städtisches Klinikum Karlsruhe Karlsruhe
Germany Hauptstraße 1a Neusaß
Germany Universitätsklinikum Tübingen Tübingen
Germany Universitätsklinikum Würzburg Würzburg
Hungary Semmelweis Egyetem Budapest
Hungary Jósa András Oktató Kórház Nyíregyháza
Israel Carmel Medical Center Haifa Israël Haifa
Israel Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel-Aviv
Italy Ospedali Riuniti di Bergamo Bergamo
Italy Azienda Ospedaliera-Universitaria Ferrara
Italy A.O.U. Policlinico "G. Martino Messina
Italy II Università degli Studi di Napoli Napoli
Italy A.O. Villa Sofia CTO Palermo
Italy Policlinico Umberto I, Università La Sapienza Roma
Italy Università La Sapienza Roma
Italy Ospedale Mauriziano - Umberto I Torino
Jordan Jordan Hospital Amman
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Seoul National University Bundang Hospital Gyeonggi-Do
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Pusan National University Yangsan Hospital Yangsan
Latvia National Rehabilitation center "Vaivari" Jurmala
Latvia P. Stradins Clinical University hospital Riga
Lebanon Hopital Hotel Dieu Beirut
Lebanon Centre Hospitalier Universitaire Notre Dame de Secours Jbaïl
Malaysia Hospital Kuala Lumpur Kuala Lumpur
Malaysia University of Malaysia Kuala Lumpur
Mexico Hospital General Dr. Santiago Ramón y Cajal Durango
Mexico Hospital General de México Mexico City
Mexico Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez" Mexico City
Mexico Nuevo Hospital Obregón Mexico City
Mexico Centro de Rehabilitación Integral de Querétaro Querétaro
Mexico Centro Medico Zambrano Hellion San Pedro Garza Garcia Nuevo Leon
Philippines Metropolitan Medical Center Manila
Philippines St Luke's Medical Center Quezon
Poland Specjalistyczna Praktyka Lekarska Katowice
Poland Medical University of Warsaw Warsaw
Portugal Centro Hospitalar Lisboa Norte Lisbon
Portugal Centro Hospitalar do Porto Porto
Portugal Hospital São Bernardo Setùbal
Portugal Centro Hospitalar de Trás-os-Montes e Alto Douro Vila Real
Romania Spitalul Universitar de Urgenta Bucuresti, neurologie Bucuresti
Romania Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II Timisoara
Russian Federation The Chelyabinsk state medical academy, Chelyabinsk
Russian Federation State Institution "Interregional clinical diagnostic centre" Kazan
Russian Federation 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
Russian Federation State Federal Budgetary Institution Scientific Center of Neurology RAMS Moscow
Russian Federation State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" St-Peterburg
Serbia Clinical Center of Serbia Belgrade
Serbia Military Medical Academy Belgrade
Singapore Singapore General Hospital Singapore
Slovenia University Medical Centre Ljubljana Ljubljana
Slovenia University Clinical Centre Maribor Maribor
Sweden Stortorgets Neurologmottagning Helsingborg
Sweden Universtitessjukhuset i Linköping Linköping
Sweden Skånes University Hospital Malmö
Sweden Neuroenheten Utsikten Stockholm
Sweden Norrlands Universitetssjukhus (NUS) Umeå
Sweden Uppsala University Hospital Uppsala
Taiwan Kaohsiung Chang-gung Memorial Hospital Kaohsiung
Taiwan TaiChung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Thailand King Chulalongkorn Memorial Hospital Bangkok
Thailand Siriraj Hospital Bangkok
Turkey Gazi University Medical Faculty Ankara
Turkey Hacettepe University Medical Faculty Ankara
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul
Turkey Dogu Mersin University Hospital Mersin
United Arab Emirates Rashid Hospital Dubai
United Kingdom Royal Devon & Exeter Hospital Exeter
United Kingdom Leeds General Infirmary Leeds
United Kingdom Neurology, John Radcliffe Hospital Oxford
United Kingdom Queen's Hospital Romford Romford
United States Tufts Medical Center, Inc Boston Massachusetts
United States Parkinson's and Movement Disorders Center of Maryland Elkridge Maryland
United States Vanderbilt University Nashville Tennessee
United States The Parkinson's and Movement Disorders Center Southfield Michigan

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

United States,  Algeria,  Australia,  Austria,  Belgium,  Brazil,  China,  Czechia,  Estonia,  France,  Germany,  Hungary,  Israel,  Italy,  Jordan,  Korea, Republic of,  Latvia,  Lebanon,  Malaysia,  Mexico,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovenia,  Sweden,  Taiwan,  Thailand,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and at every 3 to 4 months, up to 3 years.
Secondary Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score and severity sub-scale. Assessment of severity of CD. Baseline and at every 3 to 4 months, up to 3 years.
Secondary Change in tremor associated with CD using Tsui score Baseline and at every 3 to 4 months, up to 3 years.
Secondary Change in pain relief assessed using the TWSTRS pain sub-scale. Baseline and at every 3 to 4 months, up to 3 years.
Secondary Change in disability will be measured with the TWSTRS disability sub-scale. Baseline and at every 3 to 4 months, up to 3 years.
Secondary Pharmaco-economic endpoints Time intervals between injections
Changes in concomitant treatments for CD and associated symptoms.
Changes in employment status
Baseline and at every 3 to 4 months, up to 3 years.
See also
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Not yet recruiting NCT04057911 - A Trial of Non-invasive Stimulation in Cervical Dystonia N/A
Withdrawn NCT02180139 - tDCS in Cervical Dystonia N/A
Completed NCT00541905 - Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia Phase 4
Unknown status NCT00418925 - Efficacy of Dronabinol for the Treatment of Cervical Dystonia Phase 2
Not yet recruiting NCT05715138 - Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia N/A
Completed NCT02959645 - Assessment of Brain Activities in Cervical Dystonia
Completed NCT02131467 - Safety and Tolerability of Perampanel in Cervical Dystonia Phase 1/Phase 2
Completed NCT03805152 - Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia Phase 3
Completed NCT04949594 - Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Recruiting NCT01664013 - The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients Phase 4
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00447772 - Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia Phase 3
Completed NCT05157100 - Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia Phase 4
Completed NCT00257660 - Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia Phase 3
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
Completed NCT00323765 - Plasticity in Cervical Dystonia N/A
Completed NCT04171258 - Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Phase 1
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2