Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00564681

Purpose

Study is to investigate the use of the TWSTRS scale in a cervical dystonia population treated with botulinum toxin type A, and placebo

Condition	Intervention	Phase
Cervical Dystonia	Biological: botulinum toxin type A Drug: Normal Saline	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

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

MedlinePlus related topics: Botox Dystonia

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

TWSTRS change from baseline [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Global Assessment [ Time Frame: Post-treatment Week 2, Week 4, Treatment 2 and 3, Telephone, Exit ] [ Designated as safety issue: No ]
Physician's global assessment scale [ Time Frame: Post-treatment Week 2, Week 4, Treatment 2 and 3, Exit ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2007
Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 botulinum toxin type A	Biological: botulinum toxin type A Intramuscular injections of the assigned study medication into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments. Other Name: BOTOX®
Active Comparator: 2 botulinum toxin type A	Biological: botulinum toxin type A Intramuscular injections of the assigned study medication into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments
Placebo Comparator: 3 Normal Saline	Drug: Normal Saline Intramuscular injections of the assigned study medication into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of cervical dystonia

Exclusion Criteria:

Current or previous botulinum toxin treatment of any type for any condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564681

Locations

United States, North Carolina

Winston-Salem, North Carolina, United States
Canada, Nova Scotia

Halifax, Nova Scotia, Canada
Czech Republic

Prague, Czech Republic
Germany

Berlin, Germany
Hungary

Budapest, Hungary
India

Mumbai, India
Philippines

Manila, Philippines
Poland

Warsaw, Poland
Russian Federation

Moscow, Russian Federation
Serbia

Belgrade, Serbia
Singapore

Singapore, Singapore
Slovakia

Banska Bystrica, Slovakia
South Africa

Johannesburg, South Africa
Taiwan

Tainan, Taiwan
Thailand

Bangkok, Thailand
United Kingdom

Bristol, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00564681 History of Changes
Other Study ID Numbers:	191622-090
Study First Received:	November 26, 2007
Last Updated:	September 24, 2010
Health Authority:	United States: Food and Drug Administration

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
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012