Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00302393 · ClinicalTrials.gov registry record · Phase 3
Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT00302393: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT00302393 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00302393, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formulation of MPH (OROS-MPH) using positron emission tomography (PET) scanning with C-11 altropane as the ligand. The investigators hypothesize that central nervous system (CNS) DAT occupancy of the OROS-MPH to IR-MPH sequence will be greater than that of IR-MPH to OROS-MPH sequence at 5 hours after the initial administration and that the CNS DAT occupancy of the other two formulations will be intermediate. The second aim of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release.
Primary Outcome
The first visit will consist of a baseline PET scan during which no medication will be administered. For the next four study visits, subjects will be administered a first dose of one of the study treatments at hour 0 and then a second dose of one of the study treatments at hour 4. The study visits may be scheduled five to 30 days apart, but each subject must complete the five visits within a ten-week period.
Interventions
- DRUG methylphenidate hydrochloride
- DRUG OROS methylphenidate hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00302393 record still lists
NCT00302393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which methylphenidate hydrochloride is the first listed.
NCT00302393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00302393 about?
NCT00302393 is a clinical study titled "Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults". There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic doses of a short immediate release-methylphenidate hydrochloride (IR-MPH) and a long-acting formula...
What is the current status of trial NCT00302393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2006-06. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00302393?
The interventions under investigation include: methylphenidate hydrochloride (DRUG), OROS methylphenidate hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00302393?
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 NCT00302393's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia