Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00447772

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 III

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Botox Dystonia

Drug Information available for: Clostridium botulinum toxin Botulinum toxin A

U.S. FDA Resources

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

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:	514
Study Start Date:	October 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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. polyneu-ropathy 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

Responsible Party:	Ipsen ( Bert Van Eijk )
Study ID Numbers:	A-94-52120-098
Study First Received:	March 13, 2007
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00447772
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Austria: Agency for Health and Food Safety

Keywords provided by Ipsen:

Dysport, Cervical Dystonia

Study placed in the following topic categories:

Dystonic Disorders
Signs and Symptoms
Torticollis
Botulinum Toxins
Movement Disorders

Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Botulinum Toxin Type A
Dyskinesias

Additional relevant MeSH terms:

Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009