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Completed Phase 1 Interventional

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

ClinicalTrials.gov ID: NCT01624480

Public ClinicalTrials.gov record NCT01624480. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 6:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label Study to Characterize 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01624480
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
40 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2012 (Type not available)
Primary completion
Sep 2015 (Actual)
Completion
Dec 2015 (Actual)
Last update posted
Nov 9, 2021

2012 – 2015

United States locations

U.S. sites
23
U.S. states
14
U.S. cities
21
Facility City State ZIP Site status
Teva Investigational Site 12 Birmingham Alabama — —
Teva Investigational Site 17 Birmingham Alabama — —
Teva Investigational Site 7 Little Rock Arkansas — —
Teva Investigational Site 18 Orange California — —
Teva Investigational Site 16 San Diego California — —
Teva Investigational Site 4 Stanford California — —
Teva Investigational Site 9 Clearwater Florida — —
Teva Investigational Site 26 Miami Lakes Florida — —
Teva Investigational Site 5 Spring Hill Florida — —
Teva Investigational Site 25 Winter Park Florida — —
Teva Investigational Site 1 Atlanta Georgia — —
Teva Investigational Site 2 Atlanta Georgia — —
Teva Investigational Site 20 Louisville Kentucky — —
Teva Investigational Site 15 Grand Blanc Michigan — —
Teva Investigational Site 3 West Seneca New York — —
Teva Investigational Site 23 Raleigh North Carolina — —
Teva Investigational Site 10 Toledo Ohio — —
Teva Investigational Site 13 Oklahoma City Oklahoma — —
Teva Investigational Site 19 West Chester Pennsylvania — —
Teva Investigational Site 8 Houston Texas — —
Teva Investigational Site 14 San Antonio Texas — —
Teva Investigational Site 27 Everett Washington — —
Teva Investigational Site 24 Seattle Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01624480, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 9, 2021 · Synced Oct 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01624480 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →