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NCT00592943 · ClinicalTrials.gov registry record · Phase 1
PET Study Examining the Dopaminergic Activity of Armodafinil in Adults
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00592943: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT00592943 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00592943, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The specific aims of this study are 1) to document the Dopamine Transporter (DAT) receptor occupancy of armodafinil using positron emission tomography (PET) scanning with C-11 altropane as the ligand and 2) to document the increased intrasynaptic dopamine produced by armodafinil using PET scanning with C-11 raclopride as the ligand. We hypothesize that DAT occupancy will be low with armodafinil; less than the DAT occupancy produced by therapeutic doses of methylphenidate. We also hypothesize that increases in intrasynaptic dopamine will be relatively low with armodafinil.
Primary Outcome
Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using \[1 1 C\]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline).
Interventions
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT00592943 record still lists
NCT00592943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which armodafinil is the first listed.
NCT00592943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00592943 about?
NCT00592943 is a clinical study titled "PET Study Examining the Dopaminergic Activity of Armodafinil in Adults". The specific aims of this study are 1) to document the Dopamine Transporter (DAT) receptor occupancy of armodafinil using positron emission tomography (PET) scanning with C-11 altropane as the ligand and 2) to document the increased intrasynaptic dopamine produced by armodafinil using PET scanning w...
What is the current status of trial NCT00592943?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-10. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00592943?
The interventions under investigation include: armodafinil (DRUG).
Who is sponsoring clinical trial NCT00592943?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00592943's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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