Trials / Completed
CompletedNCT02274766
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- Adamas Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 30 Years – 85 Years
- Healthy volunteers
- Not accepted
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 Parkinson's 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ADS-5102 | Oral capsules to be administered once nightly at bedtime, for 13 weeks. |
| OTHER | Placebo | Oral capsules to be administered once nightly at bedtime, for 13 weeks. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-03-10
- Completion
- 2016-03-10
- First posted
- 2014-10-24
- Last updated
- 2018-01-10
- Results posted
- 2018-01-10
Locations
51 sites across 5 countries: United States, Austria, France, Germany, Spain
Source: ClinicalTrials.gov record NCT02274766. Inclusion in this directory is not an endorsement.