Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-03-05 @ 3:01 PM
Study NCT ID:
NCT00531466
Status:
TERMINATED
Last Update Posted:
2008-11-04
First Post:
2007-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Sponsor:
Avigen
Organization:
Study Overview
Official Title:
AV650-014: A Four Week, Prospective, Randomized, Double Blind, Placebo-Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV650 in Patients With Spasticity Due to Spinal Cord Injury
Status:
TERMINATED
Status Verified Date:
2008-11
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:
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes:
1. To determine whether AV650 is safe for patients with spinal cord injury;
2. To assess what the body does with AV650 once it is ingested; and,
3. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
1. To determine whether AV650 is safe for patients with spinal cord injury;
2. To assess what the body does with AV650 once it is ingested; and,
3. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with spinal cord injury.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: