NCT00165776

Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: —

Summary

To evaluate efficacy and safety of E2014 (2500U, 5000U, 10000U, placebo) in a multicenter, randomized, double-blind, parallel group comparative study by intramuscularly administering to patients with spasmodic torticollis. Primary endpoint for efficacy evaluation is changes in TWSTRS total scores from baseline measured at Week 4 and the clinical recommended dose will be examined with Williams multiple comparison. For safety evaluation, an inter group comparison (active drug and placebo) will be performed mainly focusing on incidence of adverse events, adverse drug reactions, and abnormal changes in laboratory parameters.

Conditions

• Cervical Dystonia
• Spasmodic Torticollis

Interventions

Type	Name	Description
DRUG	BOTULINUM TOXIN TYPE B

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-05-01
• Completion: 2006-11-01
• First posted: 2005-09-14
• Last updated: 2014-03-10
• Results posted: 2014-01-08

Locations

21 sites across 1 country: Japan