Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447772
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : July 24, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Cervical Dystonia Drug: Botulinum type A toxin (Dysport®) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1 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

Primary Outcome Measures :
  1. Change in Tsui score [ Time Frame: Week 4 versus baseline in week 0 ]

Secondary Outcome Measures :
  1. Recording of quality of life (disease specific quality of life questionnaire) [ Time Frame: Week 0, 4, 12 ]
  2. Evaluation of efficacy and safety/tolerability by investigator and patient [ Time Frame: Week 4, 12 ]
  3. Documentation of the dose and of the injection protocol for any subsequent injections [ Time Frame: Week 12 ]
  4. Descriptive analysis of subgroups [ Time Frame: Week 0, 4, 12 ]
  5. Tsui score profile (while patient is sitting) [ Time Frame: Week 0, 4, 12 ]
  6. Optional: additional determination of Tsui score (while patient is walking) [ Time Frame: Week 0, 4, 12 ]
  7. Comparison of Tsui scores with patient sitting and patient walking [ Time Frame: Week 0, 4, 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • De novo patients with cervical dystonia
  • Outpatient
  • Patients to be of age 18 years or older
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Pre-treatment of cervical dystonia with botulinum toxin
  • Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
  • Pure retro- or antecollis
  • Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447772

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Sponsors and Collaborators
Study Director: Bert Van Eijk, MD Ipsen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bert Van Eijk, Ipsen Identifier: NCT00447772     History of Changes
Other Study ID Numbers: A-94-52120-098
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Ipsen:
Dysport, Cervical Dystonia

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
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