Clinical Trials Directory

Trials / Completed

CompletedNCT00564681

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
242 (actual)
Sponsor
Allergan · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

Conditions

Interventions

TypeNameDescription
BIOLOGICALbotulinum toxin type AIntramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
BIOLOGICALbotulinum toxin type A Formulation 2Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
DRUGNormal SalineIntramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.

Timeline

Start date
2007-12-01
Primary completion
2008-12-01
Completion
2009-12-01
First posted
2007-11-28
Last updated
2016-01-05
Results posted
2012-12-11

Locations

16 sites across 16 countries: United States, Canada, Czechia, Germany, Hungary, India, Philippines, Poland, Russia, Serbia, Singapore, Slovakia, South Africa, Taiwan, Thailand, United Kingdom

Source: ClinicalTrials.gov record NCT00564681. Inclusion in this directory is not an endorsement.