Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465738
Status:
COMPLETED
Last Update Posted:
2010-12-31
First Post:
2007-04-24
Brief Title:
IncobotulinumtoxinA Xeomin for Upper Limb Spasticity
Sponsor:
Merz Pharmaceuticals GmbH
Organization:
Merz Pharmaceuticals GmbH
Study Overview
Official Title:
Prospective Randomized Observer-blind Parallel-group Multi-center Trial to Assess Efficacy and Safety of Two Different Dilutions of incobotulinumtoxinA Xeomin in Patients With Upper Limb Spasticity
Status:
COMPLETED
Status Verified Date:
2010-12
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:
NT-Spin
Brief Summary:
This study will investigate the efficacy and safety of incobotulinumtoxinA Xeomin in the treatment of arm tightness upper limb spasticity using two different dilutions of incobotulinumtoxinA Xeomin
Detailed Description:
IncobotulinumtoxinA Xeomin is a botulinum toxin type A preparation free of complexing proteins Injected into a muscle incobotulinumtoxinA causes a reversible local weakening of the muscle for several months and may improve an impaired muscle function by lessening the muscle tightness within few days IncobotulinumtoxinA is widely used for various severe neurological conditions There is some evidence that the treatment effect may be influenced by the amount of the solvent in which incobotulinumtoxinA is diluted before injection
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