Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358293
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2006-07-27
Brief Title:
Study of Nighttime Dosing of Sublingual Tizanidine 12 mg in Multiple Sclerosis MS Patients With Significant Spasticity
Sponsor:
Teva GTC
Organization:
Teva GTC
Study Overview
Official Title:
A Double-Blind Randomized Crossover Study to Evaluate the Clinical Efficacy and Safety of Oral Tizanidine HCl 12 mg Versus Novel Sublingual Tizanidine HCl 12 mg for the Treatment of Spasticity in MS Patients
Status:
COMPLETED
Status Verified Date:
2007-04
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:
Nightly administration of 8 mg of a unique sublingual under the tongue formulation of tizanidine a known anti-spasticity medication has been shown in a previous study to improve next-day spasticity about 12 hours following dosing in 20 multiple sclerosis MS patients This improvement was statistically significant when compared to oral tizanidine dosing The current study is being undertaken to see if increasing the dose to 12 mg once nightly will result in an even greater improvement with a longer effect ie next day improvement in spasticity both in the morning as well as in the late afternoon
Detailed Description:
Sublingual tizanidine a novel test formulation of the known effective antispasticity agent has been shown to have a unique pharmacokinetic profile ie nearly twice the bioavailabilityAUC but with little or no increase in peak plasma levels Cmax as compared to oral tizanidine Zanaflex When administered nightly to 20 MS patients at a dose of 8 mg it was shown to improve next-day spasticity statistically significant improvement in Ashworth scores about 12 hours post-dosing improvement in nighttime first quartile sleep efficiency as demonstrated by actigraphic measurement and no increase in daytime somnolence
Current study is being undertaken to evaluate if increased dosing 12 mg once nightly of sublingual tizanidine vs oral will show a concomitant increase in clinical effect ie longer improvement with next-day spasticity score improvement both in AM as previously as well as at PM late afternoon evaluation with no increase in daytime somnolence
Current study is being undertaken to evaluate if increased dosing 12 mg once nightly of sublingual tizanidine vs oral will show a concomitant increase in clinical effect ie longer improvement with next-day spasticity score improvement both in AM as previously as well as at PM late afternoon evaluation with no increase in daytime somnolence
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