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

Condition(s) targeted: Cervical Dystonia

Intervention: Botulinum type A toxin (Dysport RU®) (Drug); Botulinum type A toxin (Dysport®) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Ipsen Study Director, Study Director, Affiliation: Ipsen

Overall contact:
Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score following first treatment

Secondary outcome:

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score following first treatment

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score following first treatment

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score following first treatment

Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia following first treatment

Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia following first treatment

Proportion of treatment responders

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score for treatment cycles 2 to 5

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score for treatment cycles 2 to 5

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score for treatment cycles 2 to 5

Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score for treatment cycles 2 to 5

Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia for treatment cycles 2 to 5

Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia for treatment cycles 2 to 5

Proportion of treatment responders

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Ipsen Recruitment Enquiries, Email: clinical.trials@ipsen.com

Univ.-Klinik für Neurologie, Innsbruck, Austria; Recruiting

Univ.-Klinik für Neurologie, Wien, Austria; Not yet recruiting

AZ St. Jan, Brugge, Belgium; Recruiting

Universitair Ziekenhuis Antwerpen, Edegem, Belgium; Recruiting

HH Ziekenhuis, Roeselare, Belgium; Not yet recruiting

Fakultni nemocnice Brno, Brno, Czech Republic; Not yet recruiting

Pardubicka krajska nemocnice, Pardubice, Czech Republic; Recruiting

RESEARCH SITE s.r.o., Plzen, Czech Republic; Recruiting

Vseobecna fakultni nemocnice v Praze, Praha, Czech Republic; Recruiting

CHU Amiens, Amiens, France; Recruiting

Hopital Neurologique, Bron, France; Recruiting

CHU Caremeau, Nîmes, France; Recruiting

CHU Bordeaux, Pessac, France; Recruiting

Hopital Purpan, Toulouse, France; Recruiting

Neurologische Klinik u. Poliklinik, Berlin, Germany; Recruiting

Neurologische Klinik u. Poliklinik, Bonn, Germany; Not yet recruiting

Neurologische Klinik, Düsseldorf, Germany; Recruiting

Neurologische Klinik, Halle, Germany; Not yet recruiting

Neurologische Klinik, Hannover, Germany; Not yet recruiting

Neurologische Klinik, München, Germany; Recruiting

Neurologische Klinik, Wiesbaden, Germany; Recruiting

Semmelweis Egyetem, Budapest, Hungary; Recruiting

Jósa András Oktató Kórház Nonprofit Kft., Nyíregyháza, Hungary; Not yet recruiting

Pécsi Tudományegyetem, Pécs, Hungary; Recruiting

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, Hungary; Not yet recruiting

Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku, Gdansk, Poland; Not yet recruiting

Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala, Katowice, Poland; Not yet recruiting

Miedzyleski Szpital Specjalistyczny, Warszawa, Poland; Not yet recruiting

Akademicki Szpital Kliniczny we Wroclawiu im. Jana Mikulicza-Radeckiego, Wroclaw, Poland; Not yet recruiting

Hospitais da Universidade de Coimbra, Coimbra, Portugal; Not yet recruiting

Hospital Santa Maria, Lisboa, Portugal; Recruiting

Hospital Geral de Santo Antonio, Porto, Portugal; Not yet recruiting

Research Center of Neurology of RAMS, Moscow, Russian Federation; Not yet recruiting

Samara Regional Clinical Hospital, Samara, Russian Federation; Not yet recruiting

Smolensk State Medical Academy Smolensk Regional Clinical Hospital, Smolensk, Russian Federation; Not yet recruiting

Russian Medical Military Academy n.a. S.M.Kirov, St. Petersburg, Russian Federation; Not yet recruiting

Bukovinian Medical State University, Chernivtsi, Ukraine; Not yet recruiting

Ukrainian State Institute of Medical and Social Problems of Disability, Dnipropetrovsk, Ukraine; Not yet recruiting

Institute of Neurology, Psychiatry and Narcology AMS of Ukraine, Kharkiv, Ukraine; Not yet recruiting

Vinnytsya National Medical University, Vinnytsya, Ukraine; Not yet recruiting

Hope General Hospital, Phoenix, Arizona 85050, United States; Not yet recruiting

Parkinson's and Movement Disorder Institute, Fountain Valley, California 92708, United States; Not yet recruiting

University of Southern California, Los Angeles, California 90089, United States; Not yet recruiting

Pacific Neuroscience Research Institute, Oxnard, California 93030, United States; Not yet recruiting

University of California, San Francisco, California 94117, United States; Not yet recruiting

Associated Neurologist of Southern Connecticut, Fairfield, Connecticut 06825, United States; Not yet recruiting

Yale University School of Medicine, New Haven, Connecticut 06510, United States; Not yet recruiting

Georgetown University, Washington, District of Columbia 20007, United States; Not yet recruiting

Boca Raton Medical Center, Boca Raton, Florida 33486, United States; Not yet recruiting

University of Miami Medical Center, Miami, Florida 33136, United States; Not yet recruiting

Parkinson's Disease Treatment Center of Southwest Florida, Port Charlotte, Florida 33980, United States; Not yet recruiting

Department of Neurology, Movement St. Petersburg, St Petersburg, Florida 33701, United States; Not yet recruiting

University of South Florida, Tampa, Florida 33606, United States; Not yet recruiting

1100 Johnson Ferry Road NE suite 420, Atlanta, Georgia 30342, United States; Not yet recruiting

Department of Neurology, Movement, Disorders Program, Augusta, Georgia 30912, United States; Not yet recruiting

Rush University Medical Center, Chicago, Illinois 60612, United States; Not yet recruiting

Quest Research, Bingham Farms, Michigan 48025, United States; Not yet recruiting

Kingston Neurological Associates, Kingston, New York 12401, United States; Not yet recruiting

Island Neurological Associates, P.C., Plainview, New York 11803, United States; Not yet recruiting

Neurological Disorders Clinic, Durham, North Carolina 27705, United States; Not yet recruiting

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States; Not yet recruiting

Cleveland Clinic Foundation, Cleveland, Ohio 44106, United States; Not yet recruiting

Oregon Health and Science University, Portland, Oregon 97201, United States; Not yet recruiting

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107, United States; Not yet recruiting

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Not yet recruiting

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Not yet recruiting

Baylor College of Medicine, Houston, Texas 77030, United States; Not yet recruiting

Evergreen Hospital Medical Center, Kirkland, Washington 98034, United States; Not yet recruiting

Swedish Medical Center, Seattle, Washington 98104, United States; Not yet recruiting

Starting date: April 2011
Last updated: September 29, 2011