Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02274766
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2014-10-22
Brief Title:
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
Sponsor:
Adamas Pharmaceuticals Inc
Organization:
Adamas Pharmaceuticals Inc
Study Overview
Official Title:
ADS-5102 Amantadine HCl Extended Release Efficacy and Safety Study in Parkinsons Disease Patients With Levodopa-Induced Dyskinesia EASE LID 3 Study
Status:
COMPLETED
Status Verified Date:
2018-01
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:
EASE LID 3
Brief Summary:
This is a multi-center randomized double-blind placebo-controlled 2-arm parallel group study to evaluate the efficacy and safety of ADS-5102 extended release ER capsules an investigational formulation of amantadine dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia LID in subjects with Parkinsons disease PD The novel pharmacokinetic profile of ADS-5102 is expected to achieve i maximal concentrations in the early morning through mid-day when LID can be troublesome and ii lower concentrations in the evening potentially reducing the negative impact of amantadine on sleep This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation The once-nightly dosing regimen may also provide enhanced convenience and compliance
In a previous clinical study ADS-5102 met its primary endpoint LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs placebo
In a previous clinical study ADS-5102 met its primary endpoint LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs placebo
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