Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165776
Status:
COMPLETED
Last Update Posted:
2014-03-10
First Post:
2005-09-12
Brief Title:
Randomized Double-Blind Placebo-Controlled Parallel Group Dose-Response Study of E2014 in Patients WIth Spasmodic Torticollis
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Parallel Group Dose-Response Study of E2014 in Patients WIth Spasmodic Torticollis
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None