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 - Full Text View

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:

Genetics Home Reference related topics: dopa-responsive dystonia early-onset primary dystonia

MedlinePlus related topics: Botox Dystonia

Drug Information available for: OnabotulinumtoxinA

Genetic and Rare Diseases Information Center resources: Cervical Dystonia

U.S. FDA Resources

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

Show 57 Study Locations

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 Dyskinesias Nervous System Diseases Neurologic Manifestations Signs and Symptoms	Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015