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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00447772
First received: March 13, 2007
Last updated: July 23, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Cervical Dystonia
 Drug: Botulinum type A toxin (Dysport®)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Botox Dystonia
U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in Tsui score [ Time Frame: Week 4 versus baseline in week 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of quality of life (disease specific quality of life questionnaire) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Evaluation of efficacy and safety/tolerability by investigator and patient [ Time Frame: Week 4, 12 ] [ Designated as safety issue: Yes ]
  • Documentation of the dose and of the injection protocol for any subsequent injections [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Descriptive analysis of subgroups [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Tsui score profile (while patient is sitting) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Optional: additional determination of Tsui score (while patient is walking) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Comparison of Tsui scores with patient sitting and patient walking [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]

Enrollment: 516
Study Start Date: October 2004
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447772

  Show 106 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Bert Van Eijk, MD Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bert Van Eijk, Ipsen
ClinicalTrials.gov Identifier: NCT00447772     History of Changes
Other Study ID Numbers: A-94-52120-098
Study First Received: March 13, 2007
Last Updated: July 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by Ipsen:
Dysport, Cervical Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013