Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02471222
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2015-06-11
Brief Title:
Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Sponsor:
Adamas Pharmaceuticals Inc
Organization:
Adamas Pharmaceuticals Inc
Study Overview
Official Title:
Safety and Efficacy of ADS-5102 Amantadine HCl Extended Release Capsules in Patients With Multiple Sclerosis and Walking Impairment
Status:
COMPLETED
Status Verified Date:
2017-08
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:
This is a multi-center randomized double-blind placebo-controlled 2-arm parallel group study of ADS-5102 extended release ER capsules an investigational formulation of amantadine dosed once daily at bedtime for the treatment of walking impairment in MS ADS-5102 is designed to be administered once daily at bed time ADS-5102 achieves higher plasma amantadine concentrations in the early morning sustained throughout the afternoon and lower concentrations in the evening when patients are sleeping ADS-5102 is designed to deliver its primary treatment effect during the day and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep
Detailed Description:
None
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