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NCT01624480 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
A Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01624480: Completed Phase 1 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01624480 is a Phase 1 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624480, a Phase 1 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
Interventions
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01624480 record still lists
NCT01624480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT01624480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01624480 about?
NCT01624480 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy". This study is to evaluate the pharmacokinetics, pharmacodynamics, and safety of single and multiple doses of armodafinil (50, 100, and 150 mg/day) in children and adolescents with excessive sleepiness associated with narcolepsy.
What is the current status of trial NCT01624480?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-07. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01624480?
The interventions under investigation include: Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01624480?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01624480's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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