A Phase 2 interventional study of AP-472 and Placebo in Parkinson Disease, sponsored by Appello Pharmaceuticals, Inc.. Recruiting at 30 sites in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Appello Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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 14 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 a 12-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Appello Pharmaceuticals, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participants must meet all of the following criteria to take part in the study:
Key Exclusion Criteria:
Participants cannot take part in the study if any of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AP-472 100 mg per day
Drug: AP-472 · Other: Placebo
AP-472 300 mg per day
Drug: AP-472
Other: Placebo
Oral tablet
Oral tablet
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
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.
Of 96 industry-sponsored phase 2 interventional studies under Parkinson Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 33. This study's planned 18 months is close to that.
Counting every sponsor, half of 201 studies reached it within 28 months; a quarter within 16 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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