CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 242 enrolled
Drug / intervention
botulinum toxin type A +2 morebiological
Likely dose
botulinum toxin type A 360 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00564681
NCT00564681Phase 2Completed
CompareCT.gov

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

Allergan·interventional·Posted Nov 28, 2007·Updated Jan 5, 2016

In Brief

A Phase 2 clinical trial evaluating botulinum toxin type A, botulinum toxin type A Formulation 2, and 1 other intervention for Cervical Dystonia. Completed, enrolled 242 participants across 16 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dystonia
CountriesCanada, Czechia, Germany, Hungary, India, Philippines, Poland, Russia, Serbia, Singapore, Slovakia, South Africa, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 28, 2007
Enrollment StartDec 1, 2007
Primary CompletionDec 1, 2008
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.6 years ago

Interventions

botulinum toxin type Abiological

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

botulinum toxin type A Formulation 2biological

Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.

Normal Salinedrug

Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.