Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287157
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2006-02-02
Brief Title:
Pilot Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury TBI
Sponsor:
Teva GTC
Organization:
Teva GTC
Study Overview
Official Title:
A Double-Blind Randomized Two-Way Crossover Comparative Study to Evaluate the Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl Versus Placebo in Children With Chronic Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2007-09
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 a unique sublingual under the tongue formulation of tizanidine a known anti-spasticity medication has been shown in a previous study to improve sleep and next-day functioning in CP cerebral palsy patients It is hypothesized that this improvement in sleep efficiency iefewer wake episodes longer time asleep etc with resulting improvement in quality-of-life ieimprovements in next-day functioning cognition and movement may also be seen in a similar patient population ie children with traumatic brain injury TBI
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 CP Cerebral Palsy patients to more effectively reduce the muscle spasms that disrupt sleep it was shown to improve sleep efficiency decrease sleep fragmentation and improve the sleep cycle This improvement in night-time sleep was translated into a potential improvement in next-day functioning improvement in next-day measures of spasticity and movement
It is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity cognition and function may also be manifest in a similar patient population children with traumatic brain injury
It is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity cognition and function may also be manifest in a similar patient population children with traumatic brain injury
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