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NCT01770145 · ClinicalTrials.gov registry record · Phase 4
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)
A Phase 4 study, sponsored by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
NCT01770145: Completed Phase 4 study, sponsored by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals.
NCT01770145 is a Phase 4 study that has completed, run by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals. The registered enrollment target is 127 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01770145, a Phase 4 study, has completed, sponsored by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
Study Summary
This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
Primary Outcome
Patients will record daily "time to on" or "TTO" following their regularly scheduled first L-Dopa dose in the baseline period for 7 consecutive days. Following initiation on Apokyn therapy, patients will inject Apokyn at their regularly scheduled L-Dopa time (L-Dopa dosing will be delayed by 40 minutes following Apokyn injection) and record "time to on" or "TTO" from the injection. "Time to on" for both periods will be recorded in a standardized subject diary. Daily "TTO" for the baseline period
Interventions
- DRUG APOKYN
- DRUG L-dopa
- DRUG Trimethobenzamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT01770145 record still lists
NCT01770145 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which APOKYN is the first listed.
NCT01770145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01770145 about?
NCT01770145 is a clinical study titled "Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)". This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
What is the current status of trial NCT01770145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2012-12. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01770145?
The interventions under investigation include: APOKYN (DRUG), L-dopa (DRUG), Trimethobenzamide (DRUG).
Who is sponsoring clinical trial NCT01770145?
This trial is sponsored by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01770145's enrollment target sits among peer trials
127 639th of 2000 higher than 1,355 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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