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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 is a Phase 1 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 40 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01624480
The ClinicalTrials.gov registry entry for NCT01624480 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Armodafinil is the first listed.
NCT01624480 reports 0 study locations.
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.
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