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Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

NCT00078312 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2013-07-19

Study results available
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Summary

The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).

Conditions

  • Narcolepsy
  • Sleep Apnea, Obstructive
  • Sleep Apnea Syndromes
  • Shift-Work Sleep Disorder

Interventions

DRUG

CEP-10953 (Armodafinil)

Armodafinil (po) 100 to 250 mg/day up to 12 months

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States
  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT00078312 on ClinicalTrials.gov