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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:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01261611
First received: December 15, 2010
Last updated: February 27, 2014
Last verified: February 2014
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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 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 |
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 ]
Secondary Outcome Measures:
- Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score following first treatment [ Time Frame: Baseline and Week 4 ]
- Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score following first treatment [ Time Frame: Baseline and Week 4 ]
- Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score following first treatment [ Time Frame: Baseline and Week 4 ]
- Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ]
- Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ]
- Proportion of treatment responders [ Time Frame: Baseline and Week 4 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- Proportion of treatment responders [ Time Frame: Treatment cycle Baseline and Week 4 ]
| 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 (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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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
Show 57 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261611
Show 57 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Study Director | Ipsen |
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 ) |
| Study First Received: | December 15, 2010 |
| Last Updated: | February 27, 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 |
ClinicalTrials.gov processed this record on August 22, 2017