Ignite Creation Date:
2024-05-05 @ 11:25 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01324232
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2011-03-23
Brief Title:
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
Sponsor:
Avanir Pharmaceuticals
Organization:
Avanir Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Double-blind Randomized Placebo-controlled Four-arm Multicenter Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 DextromethorphanQuinidine in the Treatment of Central Neuropathic Pain in Patients With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2021-10
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:
PRIME
Brief Summary:
The objectives of the study are to evaluate the safety tolerability and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis
Detailed Description:
The objectives of the study are to evaluate the safety tolerability and efficacy of 3 doses of AVP-923 dextromethorphan DMquinidine Q capsules containing either 45 mg DM and 10 mg Q AVP-923-45 or 30 mg DM and 10 mg Q AVP-923-30 or 20 mg DM and 10 mg Q AVP-923-20 compared to placebo for the treatment of central neuropathic pain in a population of participants with multiple sclerosis MS over a 12-week period The MS participant population enrolled includes participants with relapsing-remitting multiple sclerosis RRMS and participants with secondary progressive multiple sclerosis SPMS
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