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

Tracking Information

First Received Date ^ICMJE

November 26, 2007

Last Updated Date

May 19, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

TWSTRS Score

Change History

Complete list of historical versions of study NCT00564681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Patient Global Assessment, Physician Global Assessment

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cervical Dystonia

Intervention ^ICMJE

Biological: botulinum toxin type A
Drug: Normal Saline

Study Arms / Comparison Groups

Active Comparator: botulinum toxin type A
Placebo Comparator: Normal Saline

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

January 2010

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of cervical dystonia

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Czech Republic, Germany, Hungary, India, Philippines, Poland, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Taiwan, Thailand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00564681

Responsible Party

Therapeutic Area Head, Allergan, Inc.

Study ID Numbers ^ICMJE

191622-090

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP