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

NCT ID: NCT01261611

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-06-30

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.

Detailed Description

The primary study objectives will be assessed in terms of improvement of the subject's CD at a pre-defined time point after treatment. The primary study objectives are to demonstrate the superiority of Dysport NG to placebo in terms of efficacy and to test the non-inferior efficacy of Dysport NG, when compared to Dysport, in CD subjects. In addition to testing for the primary study objectives, the superiority in terms of efficacy of Dysport versus placebo, will be assessed.

This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and with the ethical principles laid down in the Declaration of Helsinki.

A large body of evidence demonstrates the safety and efficacy of Dysport across several clinical indications. This study was the first use of Dysport NG in humans with CD. The active substance (BTX-A-HAC) in Dysport NG was the same as in the currently marketed Dysport product and had the same mechanism of action. Dysport NG was, therefore, expected to have the same efficacy and safety profile in humans as Dysport, with the advantage of eliminating the potential risk of transmission of infective agents, by the substitution of plant and synthetic products for human and animal-derived products. However, due to the change of excipient, thorough assessment of the safety and efficacy of Dysport NG is necessary. Previous clinical studies indicate that the maximum effect of Dysport and maximum improvements in CD are observed approximately 4 weeks post treatment, after which there is a gradual return to baseline disease status. The Week 4 follow up visit after the first treatment cycle was therefore, chosen as the primary time point of interest. Retreatment is necessary in order to maintain the beneficial effect and the long term treatment of CD. Previously conducted long term studies demonstrate the maintenance of the therapeutic effect of Dysport following repeated treatments, with a favourable short and long term safety and immunogenicity profile.

Conditions

Cervical Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dysport NG

500U (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.

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: BIOLOGICAL

I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.

Dysport

500U (1mL) injected as intramuscular injection on day 1 of treatment cycle 1.

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type: BIOLOGICAL

I.M. injection on day 1 of treatment cycle 1.

Placebo

1mL administered as, intramuscular injection on day 1 of treatment cycle 1.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

I.M. injection on day 1 of treatment cycle 1.

Interventions

Botulinum toxin type A

I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.

Intervention Type: BIOLOGICAL

Botulinum toxin type A

I.M. injection on day 1 of treatment cycle 1.

Intervention Type: BIOLOGICAL

Placebo

I.M. injection on day 1 of treatment cycle 1.

Intervention Type: DRUG

Other Intervention Names

AbobotulinumtoxinA (DysportRU®); AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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

Countries

Australia; Austria; Belgium; Czechia; France; Germany; Hungary; Poland; Portugal; Russia; Ukraine

References

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.

Reference Type: DERIVED

PMID: 27653448 (View on PubMed)

Other Identifiers

2010-019907-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Y-52-52120-134

Identifier Type: -

Identifier Source: org_study_id