Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280280
Status:
TERMINATED
Last Update Posted:
2012-01-20
First Post:
2006-01-18
Brief Title:
Botox vs Baclofen for Upper Limb Spasticity
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Double-blind Comparison of Botox Versus Baclofen for the Treatment of Subjects With Upper Limb Spasticity - Pilot Study
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this pilot study are to evaluate the safety and efficacy of Botox compared to the safety and efficacy of oral baclofen in reducing muscle tone-related disability resulting from neurological damage or a stable neurological disorder and to evaluate drug-therapy tolerance
Detailed Description:
Spasticity results from any injury to the central nervous system including brain or spinal cord Illnesses or injuries that typically cause spasticity include cerebral palsy stroke multiple sclerosis and traumatic brain or spinal cord injury Common treatments for spasticity include physical and occupational therapy as well as oral medications such as baclofen injected medications such as botulinum neurotoxin intrathecal medications and surgical procedures The approach to the treatment of spasticity is comprehensive in nature and these therapies have been widely applied to a broad population of patients including children adults and older adults
This is a single-center randomized prospective parallel double-blind study Study duration is approximately 16 weeksAt Visit 2 Baseline Visit all eligible study subjects will be randomized to one of two treatment groups intramuscular Botox plus oral placebo or intramuscular placebo plus oral baclofen
This is a single-center randomized prospective parallel double-blind study Study duration is approximately 16 weeksAt Visit 2 Baseline Visit all eligible study subjects will be randomized to one of two treatment groups intramuscular Botox plus oral placebo or intramuscular placebo plus oral baclofen
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