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

Sponsored by:	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

MedlinePlus related topics: Botox Dystonia

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

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
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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
3: Placebo Comparator 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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Allergan Inc

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-090
Study First Received:	November 26, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00564681
Health Authority:	United States: Food and Drug Administration

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:

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