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Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

NCT00236080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2013-07-19

Study results available
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Summary

The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).

Conditions

  • Chronic Shift Work Sleep Disorder

Interventions

DRUG

PROVIGIL 200 mg

PROVIGIL 200 mg/day

DRUG

Armodafinil 250 mg

Armodafinil 250 mg/day

DRUG

Armodafinil 200 mg

Armodafinil 200 mg/day

DRUG

Armodafinil 150 mg

Armodafinil 150 mg/day

DRUG

Placebo

Matching placebo tablets

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Principal Investigators

  • Gwendolyn Neibler, DO · Cephalon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Completion
2005-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00236080 on ClinicalTrials.gov