|
|
|
|
|
|
Sponsored by: |
Eisai Limited |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165776 |
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.
Condition | Intervention | Phase |
Cervical Dystonia, Spasmodic Torticollis |
Drug: BOTULINUM TOXIN TYPE B |
Phase II |
Genetics Home Reference related topics: | early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia |
MedlinePlus related topics: | Dystonia |
Drug Information available for: | Clostridium botulinum toxin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis |
Study Start Date: | June 2004 |
Study Completion Date: | November 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Patients who are botulinum toxin-resistant in previous exposures (primary no-responder*)
*If patients who were once responder to botulinum toxin treatment but thereafter became non-responder can be included in this study.
Japan | |||||
Kyoto, Japan, 601-1434 | |||||
Osaka, Japan, 553-0003 | |||||
Japan, Chiba -prefecture | |||||
Ichihara, Chiba -prefecture, Japan, 290-0003 | |||||
Japan, Fukuoka -prefecture | |||||
Kitakyushu, Fukuoka -prefecture, Japan, 807-0804 | |||||
Japan, Hokkaido | |||||
Sapporo, Hokkaido, Japan, 060-0061 | |||||
Sapporo, Hokkaido, Japan, 060-0814 | |||||
Japan, Kagoshima-prefecture | |||||
Kagoshima, Kagoshima-prefecture, Japan, 890-0075 | |||||
Japan, Kanagawa -prefecture | |||||
Sagamihara, Kanagawa -prefecture, Japan, 228-0829 | |||||
Japan, Kanagawa-prefecture | |||||
Kawasaki, Kanagawa-prefecture, Japan, 216-0015 | |||||
Japan, Nagano-prefecture | |||||
Matsumoto, Nagano-prefecture, Japan, 390-0802 | |||||
Japan, Nara-prefecture | |||||
Kashihara, Nara-prefecture, Japan, 634-0813 | |||||
Japan, Osaka | |||||
Sakai, Osaka, Japan, 590-0132 | |||||
Moriguchi, Osaka, Japan, 570-0074 | |||||
Japan, Saitama-prefecture | |||||
Saitama, Saitama-prefecture, Japan, 338-0002 | |||||
Saitama, Saitama-prefecture, Japan, 338-0003 | |||||
Tokorozawa, Saitama-prefecture, Japan, 359-1141 | |||||
Japan, Shizuoka-prefecture | |||||
Hamamatsu, Shizuoka-prefecture, Japan, 430-0906 | |||||
Japan, Tokushima-prefecture | |||||
Tokushima, Tokushima-prefecture, Japan, 770-0042 | |||||
Japan, Tokyo | |||||
Meguro-ku, Tokyo, Japan, 153-0044 | |||||
Shinjuku-ku, Tokyo, Japan, 162-0054 | |||||
Bunkyo-ku, Tokyo, Japan, 113-0033 |
Eisai Limited |
Study Director: | Hiroki Shimizu | Development Clinical Research Department. Clinical Research Center |
ClinicalStudyResults.org ID number 3492 
  |
Study ID Numbers: | E2014-J081-131 |
First Received: | September 12, 2005 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00165776 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
|
|