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Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

2014-08-27 03:15:28 | BioPortfolio

Summary

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Excessive Sleepiness

Intervention

Armodafinil, Placebo

Location

REM Medical Sleep Center
Phoenix
Arizona
United States
85037

Status

Recruiting

Source

Cephalon

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:28-0400

Clinical Trials [209 Associated Clinical Trials listed on BioPortfolio]

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

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 ...

Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness

A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcole...

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus t...

Study to Evaluate the Effects of Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance in Adults With OSAHS Who Use nCPAP Therapy

The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep...

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

The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or ...

PubMed Articles [1967 Associated PubMed Articles listed on BioPortfolio]

Solriamfetol for the treatment of excessive sleepiness in obstructive sleep apnea: A placebo-controlled randomized-withdrawal study.

Excessive sleepiness is a common symptom of obstructive sleep apnea (OSA), which often persists despite primary OSA therapy. This phase 3 randomized-withdrawal trial evaluated solriamfetol (JZP-110) f...

Does Armodafinil Improve Driving Task Performance and Weight Loss in Sleep Apnea? A Randomized Trial.

RATIONALE Obstructive sleep apnea (OSA) patients unable to tolerate standard treatments have few alternatives. They may benefit from weight loss, but the major symptom of daytime performance impairmen...

Solriamfetol for the treatment of daytime sleepiness in obstructive sleep apnea.

Obstructive sleep apnea (OSA) is highly prevalent and constitutes a major health hazard. Current pharmacotherapy is ineffective in correcting sleep-disordered breathing and is used adjunctively to add...

Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3): A Randomized Controlled Trial.

Primary treatment of obstructive sleep apnea can be accompanied by a persistence of excessive sleepiness despite adherence. Furthermore, effectiveness of sleep apnea treatment is limited by poor adher...

Factors related to excessive sleepiness in patients with Parkinson's disease.

Excessive sleepiness (ES) can affect up to 60% of Parkinson's disease (PD) patients, and it has a multifactorial etiology. It is related to the neurodegenerative processes affecting brain regions resp...

Medical and Biotech [MESH] Definitions

A specific category of drugs that prevent sleepiness by specifically targeting sleep-mechanisms in the brain. They are used to treat DISORDERS OF EXCESSIVE SOMNOLENCE such as NARCOLEPSY. Note that this drug category does not include broadly-acting central nervous system stimulants such as AMPHETAMINES.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Excessive thirst manifested by excessive fluid intake. It is characteristic of many diseases such as DIABETES MELLITUS; DIABETES INSIPIDUS; and NEPHROGENIC DIABETES INSIPIDUS. The condition may be psychogenic in origin.

An excessive accumulation of iron in the body due to a greater than normal absorption of iron from the gastrointestinal tract or from parenteral injection. This may arise from idiopathic hemochromatosis, excessive iron intake, chronic alcoholism, certain types of refractory anemia, or transfusional hemosiderosis. (From Churchill's Illustrated Medical Dictionary, 1989)

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