Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-02 @ 6:07 PM
Study NCT ID:
NCT00532532
Status:
TERMINATED
Last Update Posted:
2008-11-04
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis
Sponsor:
Avigen
Organization:
Study Overview
Official Title:
AV650-018: A Two-Part (Double-Blind Followed by Open-Label), Placebo Controlled, Randomized Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of AV650 (Tolperisone HCl) in Subjects With Spasticity Associated With Multiple Sclerosis
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 associated with multiple sclerosis. This study has three purposes:
1. To determine whether AV650 is safe for patients with multiple sclerosis;
2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).
1. To determine whether AV650 is safe for patients with multiple sclerosis;
2. To gather some early evidence as to whether AV650 is effective in treating spasticity in patients with multiple sclerosis; and,
3. To assess what the body does with AV650 once it is ingested (Germany and Czech Republic sites only).
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?: