Study Comparing Short Term Efficacy of Dysport® and Dysport RU® to Placebo, and to Assess Efficacy and Safety of Dysport RU® of Subjects With Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01261611
First received: December 15, 2010
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate how well a new drug called Dysport RU works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be compared to an approved drug called Dysport.


Condition Intervention Phase
Cervical Dystonia
Drug: Botulinum type A toxin (Dysport RU®)
Drug: Botulinum type A toxin (Dysport®)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 RU®) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport RU® Following Repeated Treatments of Subjects With Cervical Dystonia

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Proportion of treatment responders [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Proportion of treatment responders [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]

Enrollment: 333
Study Start Date: April 2011
Study Completion Date: May 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dysport RU

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.

Drug: Botulinum type A toxin (Dysport RU®)
I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
Active Comparator: Dysport
500U (1ml) injected as intramuscular injection on day 1 of treatment cycle 1.
Drug: Botulinum type A toxin (Dysport®)
I.M. injection on day 1 of treatment cycle 1.
Placebo Comparator: Placebo
1ml administered as, intramuscular injection on day 1 of treatment cycle 1.
Drug: Placebo
I.M. injection on day 1 of treatment cycle 1.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261611

  Hide Study Locations
Locations
Australia
Monash Medical Centre
Clayton, Australia
Austin Hospital
Heidelberg, Australia
Department of Neurosciences Alfred Hospital
Prahran, Australia
Westmead Hospital
Westmead, Australia
Austria
Univ.-Klinik für Neurologie
Innsbruck, Austria
Univ.-Klinik für Neurologie
Wien, Austria
Belgium
AZ St. Jan
Brugge, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
AZ Sint Lucas
Gent, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
HH Ziekenhuis
Roeselare, Belgium
Czech Republic
Fakultni nemocnice Brno
Brno, Czech Republic
Pardubicka krajska nemocnice
Pardubice, Czech Republic
RESEARCH SITE s.r.o.
Plzen, Czech Republic
Vseobecna fakultni nemocnice v Praze
Praha, Czech Republic
France
CHU Amiens
Amiens, France
Hopital Neurologique
Bron, France
CHU Caremeau
Nîmes, France
CHU Bordeaux
Pessac, France
CHU Strasbourg
Strasbourg, France
Hopital Purpan
Toulouse, France
Germany
Neurologische Klinik u. Poliklinik
Berlin, Germany
Neurologische Klinik u. Poliklinik
Bonn, Germany
Neurologische Klinik
Düsseldorf, Germany
Neurologische Klinik
Halle, Germany
Neurologische Klinik
Hannover, Germany
Neurologische Klinik
Leipzig, Germany
Neurologische Klinik
München, Germany
Neurologische Klinik
Tübingen, Germany
Neurologische Klinik
Wiesbaden, Germany
Neurologische Klinik
Würzburg, Germany
Hungary
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
Poland
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
Warszawa, Poland
Portugal
Hospital Santa Maria
Lisboa, Portugal
Hospital Geral de Santo Antonio
Porto, Portugal
Russian Federation
Research Medical Complex "Vashe Zdorovie"
Kazan, Russian Federation
Research Center of Neurology of RAMS
Moscow, Russian Federation
Nizhniy Novgorod Research Institute for Traumatology and Orthopaedics
Nizhniy Novgorod, Russian Federation
Samara Regional Clinical Hospital
Samara, Russian Federation
Smolensk State Medical Academy Smolensk Regional Clinical Hospital
Smolensk, Russian Federation
Russian Medical Military Academy n.a. S.M.Kirov
St. Petersburg, Russian Federation
Ukraine
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"
Odessa, Ukraine
Uzhgorod National University
Uzhgorod, Ukraine
Vinnytsya National Medical University
Vinnytsya, Ukraine
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Study Director Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01261611     History of Changes
Other Study ID Numbers: Y-52-52120-134, 2010-019907-43
Study First Received: December 15, 2010
Last Updated: February 27, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Belgium: Federal Agency for Medicinal Products and Health Products
Austria: Agency for Health and Food Safety
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014