Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
NCT00228566 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247
Last updated 2013-07-19
Summary
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.
Conditions
- Excessive Daytime Sleepiness
- Narcolepsy
- Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Interventions
- DRUG
-
Armodafinil
Sponsors & Collaborators
-
Cephalon
lead INDUSTRY
Principal Investigators
-
Sponsor's Medical Expert, MD · Cephalon
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
- 2005-10-31
- Completion
- 2006-07-31
Countries
- United States
Study Locations
More Related Trials
-
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
NCT00079677 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
NCT00711516 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
NCT00983437 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
NCT01080807 ·Status: COMPLETED ·Phase: PHASE4
-
Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
NCT03772314 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury
NCT00893789 ·Status: TERMINATED ·Phase: PHASE3
-
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
NCT02151253 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
NCT00758498 ·Status: COMPLETED ·Phase: PHASE3
-
Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
NCT00080288 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL
NCT00236080 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Armodafinil on Simulated Driving
NCT02468856 ·Status: COMPLETED ·Phase: PHASE1
-
Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder
NCT00688142 ·Status: COMPLETED
-
Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss
NCT01096680 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
NCT01681121 ·Status: COMPLETED ·Phase: PHASE2
-
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
NCT00066170 ·Status: COMPLETED ·Phase: PHASE3
-
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
NCT00107809 ·Status: COMPLETED ·Phase: PHASE3
-
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
NCT02348632 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Armodafinil for Fatigue in Sarcoidosis
NCT00555347 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
NCT01485770 ·Status: COMPLETED ·Phase: PHASE2
-
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)
NCT06103825 ·Status: COMPLETED ·Phase: PHASE3
-
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
NCT04789174 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
NCT01124851 ·Status: COMPLETED ·Phase: PHASE1
-
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
NCT06767683 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants
NCT04551079 ·Status: COMPLETED ·Phase: PHASE1
-
Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia
NCT00664664 ·Status: COMPLETED ·Phase: PHASE2