Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia
2 other identifiers
interventional
382
10 countries
55
Brief Summary
The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2011
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
September 24, 2019
CompletedSeptember 28, 2022
September 1, 2022
1.1 years
December 15, 2010
April 27, 2016
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle
TWSTRS measures the degree of CD and is comprised of three different components, namely Severity, Disability and Pain subscales. There is an ordinal scale score and range for each component. Severity scores range from 0 (absence of severity) to 35 (maximum severity), Disability scores range from 0 (no disability) to 30 (maximum disability) and Pain scores range from 0 (no pain) to 20 (maximum pain). TWSTRS Total score is the sum of the 3 component scores ranging from 0 to a maximum of 85, with higher scores denoting worse outcome. If the change from baseline is negative, this represents an improvement in symptoms.
Baseline and Week 4
Secondary Outcomes (13)
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle
Baseline and Week 4
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle
Baseline and Week 4
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle
Baseline and Week 4
Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle
Baseline and Week 4
Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle
Baseline and Week 4
- +8 more secondary outcomes
Study Arms (3)
Dysport NG
EXPERIMENTAL500U (1mL) administered as intramuscular injection on day 1 of treatment cycle 1 and 2. 250U (0.5mL), 500U (1mL) or 750U (1.5mL) administered as intramuscular injection on day 1 of treatment cycle 3. 250U (0.5mL), 500U (1mL), 750U (1.5mL) or 1000U (2mL) administered as intramuscular injection on day 1 of treatment cycle 4 and 5.
Dysport
ACTIVE COMPARATOR500U (1mL) injected as intramuscular injection on day 1 of treatment cycle 1.
Placebo
PLACEBO COMPARATOR1mL administered as, intramuscular injection on day 1 of treatment cycle 1.
Interventions
I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
Eligibility Criteria
You may qualify if:
- Dystonia with at least 18 months duration since onset.
- Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks since the last injection.
- TWSTRS score at baseline of: Total score ≥ 30, Severity Sub-Scale score ≥ 15, Disability Sub-Scale score ≥ 3, Pain Sub-Scale score ≥ 2.
You may not qualify if:
- Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component in the study drug formulation (including cow milk protein).
- Pure anterocollis or pure retrocollis.
- In apparent remission from Cervical Dystonia.
- Known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
- Previous poor response to BTX treatment or known presence of BTX neutralising antibodies.
- Previous phenol or alcohol injections into the neck muscles.
- Previous myotomy or denervation surgery involving the neck or shoulder region.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (57)
Monash Medical Centre
Clayton, Australia
Austin Hospital
Heidelberg, Australia
Department of Neurosciences Alfred Hospital
Prahran, Australia
Westmead Hospital
Westmead, Australia
Univ.-Klinik für Neurologie
Innsbruck, Austria
Univ.-Klinik für Neurologie
Vienna, Austria
AZ St. Jan
Bruges, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
AZ Sint Lucas
Ghent, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
HH Ziekenhuis
Roeselare, Belgium
Fakultni nemocnice Brno
Brno, Czechia
Pardubicka krajska nemocnice
Pardubice, Czechia
RESEARCH SITE s.r.o.
Pilsen, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
CHU Amiens
Amiens, France
Hopital Neurologique
Bron, France
CHU Caremeau
Nîmes, France
CHU Bordeaux
Pessac, France
CHU Strasbourg
Strasbourg, France
Hopital Purpan
Toulouse, France
Neurologische Klinik u. Poliklinik
Berlin, Germany
Neurologische Klinik u. Poliklinik
Bonn, Germany
Neurologische Klinik
Düsseldorf, Germany
Neurologische Klinik
Halle, Germany
Neurologische Klinik
Hanover, Germany
Neurologische Klinik
Leipzig, Germany
Neurologische Klinik
München, Germany
Neurologische Klinik
Tübingen, Germany
Neurologische Klinik
Wiesbaden, Germany
Neurologische Klinik
Würzburg, Germany
Semmelweis Egyetem
Budapest, Hungary
Jósa András Oktató Kórház Nonprofit Kft.
Nyíregyháza, Hungary
Pécsi Tudományegyetem
Pécs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, Poland
Specjalistyczna Praktyka Lekarska
Katowice, Poland
Malopolskie Centrum Medyczne
Krakow, Poland
Gabinet Lekarski
Lodz, Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Poznan, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, Poland
Hospital Santa Maria
Lisbon, Portugal
Hospital Geral de Santo Antonio
Porto, Portugal
Research Medical Complex "Vashe Zdorovie"
Kazan', Russia
Research Center of Neurology of RAMS
Moscow, Russia
Nizhniy Novgorod Research Institute for Traumatology and Orthopaedics
Nizhny Novgorod, Russia
Russian Medical Military Academy n.a. S.M.Kirov
Saint Petersburg, Russia
Samara Regional Clinical Hospital
Samara, Russia
Smolensk State Medical Academy Smolensk Regional Clinical Hospital
Smolensk, Russia
Bukovinian Medical State University
Chernivtsi, Ukraine
Ukrainian State Institute of Medical and Social Problems of Disability
Dnipropetrovsk, Ukraine
Donetsk Railroad Clinical Hospital
Donetsk, Ukraine
Institute of Neurology, Psychiatry and Narcology AMS of Ukraine
Kharkiv, Ukraine
Lviv Regional Clinical Hospital
Lviv, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital"
Odesa, Ukraine
Uzhgorod National University
Uzhhorod, Ukraine
Vinnytsya National Medical University
Vinnytsia, Ukraine
Related Publications (1)
Poewe W, Burbaud P, Castelnovo G, Jost WH, Ceballos-Baumann AO, Banach M, Potulska-Chromik A, Ferreira JJ, Bihari K, Ehler E, Bares M, Dzyak LA, Belova AN, Pham E, Liu WJ, Picaut P. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. Mov Disord. 2016 Nov;31(11):1649-1657. doi: 10.1002/mds.26760. Epub 2016 Sep 21.
PMID: 27653448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Neurology
- Organization
- Ipsen Innovation
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 16, 2010
Study Start
April 1, 2011
Primary Completion
May 1, 2012
Study Completion
June 1, 2013
Last Updated
September 28, 2022
Results First Posted
September 24, 2019
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.