Clinical Trials Logo
  1. Home
  2. Excessive Sleepiness
  3. NCT00080288

Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

Excessive Sleepiness Clinical Trial

Official title:
A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder

Clinical Trial Summary

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00080288
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Completed
Phase Phase 3
Start date March 2004
Completion date December 2004
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT01766323 - Palliative Morphine With or Without Concurrent Modafinil Phase 3
Completed NCT00711516 - Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance Phase 4
Completed NCT00758498 - Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder Phase 3
Completed NCT00174174 - Provigil (Modafinil) Study by Taiwan Biotech Co. N/A
Terminated NCT04618263 - Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers Phase 1
Completed NCT01080807 - Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder Phase 4
Completed NCT02806908 - Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy Phase 2
Completed NCT02806895 - Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA Phase 2
Recruiting NCT04788953 - Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder Phase 4
Completed NCT03881852 - Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) Phase 2
Completed NCT03037203 - A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness Phase 2
Completed NCT05008341 - Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration Phase 1