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NCT03187301 · ClinicalTrials.gov registry record · Phase 2
A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes
A Phase 2 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT03187301: Completed Phase 2 study, sponsored by Sumitomo Pharma America.
NCT03187301 is a Phase 2 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03187301, a Phase 2 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
Primary Outcome
For the primary central tendency analysis, the changes from baseline (ΔQTcF) were compared between APL-130277 and placebo (ΔΔQTcF). Baseline was defined as the mean of the 9 ECGs (3 sets of triplicate ECGs) recorded at baseline (P1V1). In case any of the 9 ECGs were missing, the baseline was defined as the mean of the available baseline values. The post-dose ECGs were evaluated at 15, 30, 45 and 60 minutes (mins) and 2, 3 and 4 hours post-dose at each of the 3 treatment period dosing visits duri
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG APL-130277
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-08-03 |
| Est. Completion | 2017-12-21 |
| Phase | Phase 2 |
What the finished NCT03187301 record still lists
NCT03187301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03187301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03187301 about?
NCT03187301 is a clinical study titled "A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes". A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
What is the current status of trial NCT03187301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2017-08-03. Estimated completion is 2017-12-21.
What interventions are being tested in trial NCT03187301?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), APL-130277 (DRUG).
Who is sponsoring clinical trial NCT03187301?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03187301's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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