Trials / Completed
CompletedNCT02469090
Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APL-130277 | Use to treat up to 5 "OFF" episodes per day |
| DRUG | Placebo | placebo |
Timeline
- Start date
- 2015-06-18
- Primary completion
- 2017-12-11
- Completion
- 2017-12-11
- First posted
- 2015-06-11
- Last updated
- 2020-07-30
- Results posted
- 2020-07-30
Locations
33 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02469090. Inclusion in this directory is not an endorsement.