Comparison of Efficacy and Safety of Two Different Types of Botulinum Toxin Type A in Moderate to Severe Cervical Dystonia - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00528541

Purpose

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck

Condition	Intervention	Phase
Spasmodic Torticollis	Biological: botulinum toxin type A	Phase IV

MedlinePlus related topics: Botox Dystonia

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Comparison of incidence and severity of adverse events through use of a structured questionnaire and from patient interview [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy as measured by TWSTRS [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy as measured by Cervical Dystonia Severity [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy as measured by Physician Global Assessment [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy as measured by Patient Global Assessment [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy as measured by Patient Assessment of Retreatment [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy measured by Patient Analog Assessment of Pain [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy measured by Physician Comparison of Benefit to Previous Injection [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Efficacy measured by Patient Comparison of Benefit to Previous Injection [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]
Safety as measured by Spontaneously Reported Adverse Events [ Time Frame: Weeks 2, 4, 6, 8, 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	December 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator botulinum toxin type A (BOTOX®)	Biological: botulinum toxin type A 200 Units at Visit 1 (Day 1)
2: Active Comparator botulinum toxin type A (Dysport®)	Biological: botulinum toxin type A 750 Units at Visit 1 (Day 1)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528541

Contacts

Contact: Allergan Inc

Locations

Australia, South Australia
	Recruiting
Adelaide, South Australia, Australia
Croatia
	Recruiting
Zagreb, Croatia
Poland
	Recruiting
Krakow, Poland

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	MedAff-BTX-0616
Study First Received:	September 10, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00528541
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Dystonic Disorders
Signs and Symptoms
Torticollis
Botulinum Toxins
Movement Disorders

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

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009