Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464958
Status:
TERMINATED
Last Update Posted:
2009-02-19
First Post:
2007-04-22
Brief Title:
One Year Extension Study To Protocol C25TZMS-05
Sponsor:
Teva GTC
Organization:
Teva GTC
Study Overview
Official Title:
Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl 12 mg for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped as the sponsor is no longer funding this project
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open label one year extension study to evaluate the clinical efficacy and safety of 12 mg sublingual tizanidine administered once nightly in MS patients who successfully completed Phase III protocol C25TZMS-05 at the Tel Aviv Sourasky Medical Center Department of Neurology Dr Arnon Karni PI
Detailed Description:
The previous study Protocol C25TZ-MS-05 using 12 mg sublingual tizanidine confirmed that administration of once nightly sublingual tizanidine before sleep results in a statistically and clinically significant reduction in next-day spasticity as compared to placebo The clinical effect following 12 mg sublingual tizanidine was larger 4-5 units on the Ashworth scale and more sustained up to 18-20 hours post-dose than was seen for 8 mg tizanidine earlier study Protocol C25TZMS-03z This study also reconfirmed that the increased improvement in next-day reduction of spasticity following overnight sublingual tizanidine dosing is not accompanied by a concomitant increase in next-day somnolence
This study a 12 month open label extension will allow those patients who successfully completed Protocol C25TZ-MS-05 and who found tizanidine to be beneficial to continue treatment under close medical supervision The study will provide long-term 12 months clinical efficacy and safety data re the use of once daily sublingual tizanidine administered at night just before bedtime
This study a 12 month open label extension will allow those patients who successfully completed Protocol C25TZ-MS-05 and who found tizanidine to be beneficial to continue treatment under close medical supervision The study will provide long-term 12 months clinical efficacy and safety data re the use of once daily sublingual tizanidine administered at night just before bedtime
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