This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo. The study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given. The study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Oral tablet
Oral tablet
University of Arkansas for Medical Sciences (Site #208)
Little Rock, Arkansas, United States
NOT_YET_RECRUITINGProfound Research LLC (Site #222)
Carlsbad, California, United States
RECRUITINGCollaborative Neuroscience Network - Los Alamitos- CenExel - PPDS (Site #217)
Los Alamitos, California, United States
RECRUITINGKeck Medicine of USC - USC Healthcare Center 2 (Site #221)
Los Angeles, California, United States
Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time)
Time frame: Week 12
Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours)
Time frame: Week 12
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 2 (Motor Experiences of Daily Living (M-EDL)) score
For MDS-UPDRS Part II (Motor Experiences of Daily Living, M-EDL) there are 13 items each scored from 0 to 4. The total score range is from 0-52. A higher score indicates worse motor impact on daily activities; lower scores are better.
Time frame: Week 12
Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index
For the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index the score is calculated by averaging the 8 domain scores and converting them to a 0-100 scale. A higher score indicates worse health-related quality of life; lower scores are better.
Time frame: Week 12
Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state
The MDS-UPDRS Part III includes 33 items, each scored from 0 to 4. The total score range is from 0-132. A higher score indicates worse motor impairment; lower scores are better.
Time frame: Week 12
Change from baseline in Epworth Sleepiness Scale (ESS) total score
The ESS consists of 8 items, each scored from 0 to 3. The total score range is from 0-24. Higher scores indicate greater daytime sleepiness; lower scores are better.
Time frame: Week 12
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Parkinson's Research Centers of America (Site #218)
Palo Alto, California, United States
RECRUITINGRocky Mountain Clinical Research - CenExel - PPDS (Site #215)
Englewood, Colorado, United States
RECRUITINGParkinson's Disease & Movement Disorders Center of Boca Raton (Site #227)
Boca Raton, Florida, United States
RECRUITINGUM-UHealth at Boca Raton (Site #226)
Boca Raton, Florida, United States
RECRUITINGVelocity Clinical Research - Hallandale Beach (Site #228)
Hallandale, Florida, United States
RECRUITINGUniversity of Miami (Site #220)
Miami, Florida, United States
RECRUITING...and 20 more locations