Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: This was a multicenter double-blind study with 196 patients (aged 18-65 years) randomized to receive armodafinil 150 mg (n = 65), armodafinil 250 mg (n = 67), or placebo (n = 64) once daily for 12 weeks. MAIN OUTCOME MEASURES: Efficacy was assessed using the Maintenance of Wakefulness Test (MWT) (six 20-min subtests across the day), the Clinical Global Impression of Change (CGI-C), subjective measures of sleepiness (Epworth Sleepiness Scale), patient diaries, and evaluations of cognitive performance (Cognitive Drug Research) and fatigue (Brief Fatigue Inventory). RESULTS:
Armodafinil significantly increased MWT mean sleep latency (at 0900-1500) compared with placebo. The mean change from baseline at final visit for armodafinil was an increase of 1.3, 2.6, and 1.9 min in the 150-mg, 250-mg, and combined groups, respectively, compared with a decrease of 1.9 min for placebo (p < 0.01 for all three comparisons). Mean late-day MWT latency (1500-1900) was also significantly improved (difference of armodafinil combined group relative to placebo at final visit: 2.8 min, p = 0.0358). The proportions of patients who showed at least minimal improvement in the CGIC rating from baseline to final visit in the armodafinil 150-mg, 250-mg, and combined groups were 69%, 73%, and 71%, respectively, compared with 33% for placebo (p < 0.0001). Both doses were associated with statistically significant improvements in memory, attention, and fatigue (p < 0.05). The most common adverse events in patients receiving armodafinil were headache, nausea, and dizziness. CONCLUSIONS:
Armodafinil significantly improved ability to sustain wakefulness throughout the day in patients with narcolepsy. Armodafinil also significantly improved overall clinical condition, memory, attention, and fatigue when compared with placebo.
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Authors | John R Harsh, Roza Hayduk, Russell Rosenberg, Keith A Wesnes, James K Walsh, Sanjay Arora, Gwendolyn E Niebler, Thomas Roth |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 22
Issue 4
Pg. 761-74
(Apr 2006)
ISSN: 0300-7995 [Print] England |
PMID | 16684437
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Central Nervous System Stimulants
- Modafinil
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Topics |
- Adolescent
- Adult
- Aged
- Benzhydryl Compounds
(adverse effects, therapeutic use)
- Central Nervous System Stimulants
(adverse effects, therapeutic use)
- Double-Blind Method
- Humans
- Middle Aged
- Modafinil
- Narcolepsy
(drug therapy, physiopathology)
- Sleep Stages
(drug effects, physiology)
- Treatment Outcome
- Wakefulness
(drug effects, physiology)
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