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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00447772 |
The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.
Condition | Intervention | Phase |
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Cervical Dystonia |
Drug: Botulinum type A toxin (Dysport®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Multicentre Study to Demonstrate the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia |
Enrollment: | 514 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Botulinum type A toxin (Dysport®)
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bert Van Eijk, MD | Ipsen |
Responsible Party: | Ipsen ( Bert Van Eijk ) |
Study ID Numbers: | A-94-52120-098 |
Study First Received: | March 13, 2007 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00447772 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Austria: Agency for Health and Food Safety |
Dysport, Cervical Dystonia |
Dystonic Disorders Signs and Symptoms Torticollis Botulinum Toxins Movement Disorders Central Nervous System Diseases |
Neurologic Manifestations Dystonia Peripheral Nervous System Agents Botulinum Toxin Type A Dyskinesias |
Dystonic Disorders Nervous System Diseases Physiological Effects of Drugs Dystonia Central Nervous System Diseases Neuromuscular Agents Dyskinesias |
Pharmacologic Actions Signs and Symptoms Torticollis Movement Disorders Neurologic Manifestations Peripheral Nervous System Agents Botulinum Toxin Type A |