Table II.
Ongoing clinical trials of wake-promoting effects
| Nature of study | Study drug (s) | Title | Relevant outcomes |
|---|---|---|---|
| Direct assessment of wake- promoting effects | Armodafinil | A Randomized Placebo- Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas (NCT00766467) | Fatigue |
| Armodafinil | Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS (NCT00737204) | Fatigue severity scale; Role function scale; Cognitive function | |
| Armodafinil | Armodafinil for Fibromyalgia Fatigue (NCT00568919) | Fatigue severity scale | |
| Armodafinil | Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder (NCT00758498) | MSLT; KSS | |
| Armodafinil | Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Comorbid Major Depressive Disorder or Dysthymic Disorder (NCT00518986) | MWT; ESS | |
| Armodafinil | An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue (NCT00678691) | Brief fatigue inventory | |
| Armodafinil | Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder (NCT00688142) | ERPs | |
| MK0249 (Merck, H3 agonist); Modafinil | Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (NCT00620659) | Wake-promotion | |
| Assessment of wake promoting effects secondary to improved sleep parameters | Ramelteon | Ramelteon Night Shift Study (NCT00595075) | Neurobehavioral performance battery |
| Ramelteon | Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson’s Disease (NCT00462254) | ESS; Sleep disorder questionnaire; Hopkins verbal learning task | |
| Ramelteon | Ramelteon for Treatment of Adult Patients With ADHD- Related Insomnia (NCT00622427) | CGI (day time functioning mentioned without reference to specific assessments) | |
| Ramelteon | Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism (NCT00745030) | Sleep diary; CGI; ESS; PSQI; Fatigue Severity Scale; Mini Mental State Exam; Montreal Cognitive Assessment Scale | |
| Ramelteon | A Multicentre, Randomised, Double-Blind, Double- Dummy, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Ramelteon Compared to Placebo With Zopiclone as a Reference Arm in Adults With Chronic Insomnia (NCT00237497) | Sleep and daytime function questionnaires; DSST; memory recall | |
| Ramelteon | Improving Sleep in Nursing Homes (NCT00576927) | Daytime sleep, activity and behavior; Actigraphy | |
| Ramelteon | Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia (NCT00507546) | Daytime alertness |
Searches conducted in clinicaltrials.gov December 2008 using the terms “alerting”, “wake promoting”, “wakeful” and wakefulness” – then additional review of drugs included in search results to identify ongoing studies using assessment of wake promotion without specific mention of these terms.