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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cervical Dystonia	Drug: Botulinum type A toxin (Dysport RU®); Drug: Botulinum type A toxin (Dysport®); Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	333 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	April 2011
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2013

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score following first treatment [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures :

1. Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score following first treatment [ Time Frame: Baseline and Week 4 ]
2. Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score following first treatment [ Time Frame: Baseline and Week 4 ]
3. Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score following first treatment [ Time Frame: Baseline and Week 4 ]
4. Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ]
5. Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ]
6. Proportion of treatment responders [ Time Frame: Baseline and Week 4 ]
7. 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 ]
8. 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 ]
9. 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 ]
10. 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 ]
11. 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 ]
12. 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 ]
13. Proportion of treatment responders [ Time Frame: Treatment cycle Baseline and Week 4 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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  Show 57 Study Locations

Sponsors and Collaborators

Ipsen

Investigators

Study Director:	Ipsen Study Director	Ipsen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT01261611 History of Changes
Other Study ID Numbers:	Y-52-52120-134; 2010-019907-43 ( EudraCT Number )
First Posted:	December 16, 2010
Last Update Posted:	February 28, 2014
Last Verified:	February 2014

Additional relevant MeSH terms:

Dystonia; Dystonic Disorders; Torticollis; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; abobotulinumtoxinA	Botulinum Toxins, Type A; onabotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents