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Practical Multiple Testing Methods in Clinical Trials
Published in Mark Chang, John Balser, Jim Roach, Robin Bliss, Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials, 2019
Mark Chang, John Balser, Jim Roach, Robin Bliss
This randomized, placebo-controlled study was conducted to compare the overnight efficacy and plasma concentration-time profiles of armodafinil (250, 200, and 150 mg) in patients with chronic shift work sleep disorder (SWSD). The primary endpoint was the change in multiple sleep latency test (MSLT) from the baseline to the last visit. MSLT is an objective assessment of sleepiness that measures the likelihood of falling asleep. The details of this trial can be found at https://clinicaltrials.gov. The three individual hypotheses might be of interest:
Non-pharmacological interventions for insomnia in cancer patients
Published in S.R. Pandi-Perumal, Meera Narasimhan, Milton Kramer, Sleep and Psychosomatic Medicine, 2017
K. Gilla, Samara Perez Shapiro, Zeev Rosberger, JOSÉe Savard
In the largest RCT, comparing standard CBT-I with usual care, Espie et al.88 found significant improvements in insomnia and nighttime wakefulness, with results persisting for at least 6 months among 150 mixed diagnosis cancer patients. CBT-I was also associated with increased quality of life and reduced daytime fatigue. Similar successful outcomes were reported in the seven RCTs.77 In a recent comparative efficacy study of 96 cancer survivors, armodafinil (a psychostimulant) did not improve the reported efficacy (i.e., reductions in insomnia severity and improvements on the PSQI) when it was given in combination with CBT-I.90 In addition, the efficacy of armodafinil alone was not very different from that shown by placebo alone. These results indicate that CBT-I is a mainstay and that there appears to be no unique or added benefit associated with this medication for treating cancer-related insomnia.
Main Classes of Drugs
Published in Jerome Z. Litt, Neil H. Shear, Litt's Drug Eruption & Reaction Manual, 2017
EugeroicArmodafinil
Pharmacological management of dementia with Lewy bodies with a focus on zonisamide for treating parkinsonism
Published in Expert Opinion on Pharmacotherapy, 2021
Francesco Panza, Madia Lozupone, Mark Watling, Bruno P. Imbimbo
Loss of midbrain dopamine cells innervating the motor striatum [84] contributes to the development of motor symptoms in DLB. Levodopa can treat parkinsonian symptoms of some DLB patients [85–87], but its use may be limited by the risk of inducing motor fluctuations, agitation, or worsening visual hallucinations [88,89]. Among nonmotor symptoms of DLB, RBD can be treated with clonazepam or melatonin [57,58,90,91], although without systematic evidence of efficacy and or large-scale trials. Armodafinil, the (R)-(-)-enantiomer of racemic modafinil, is a wake-promoting agent approved for excessive sleepiness associated with narcolepsy and shift work sleep disorder. A 12-week, open-label study of armodafinil in 20 DLB patients showed improvements in hypersomnolence with reasonable safety and tolerability [92], but a case study reported exacerbation of agitation and hallucinations in a DLB patient treated with modafinil [93]. Finally, there are a wide range of autonomic signs and symptoms in DLB patients associated with more rapid disease progression and shorter survival [94]. However, no RCTs for patients with DLB have been conducted for autonomic symptoms [58]. Therefore, treatment recommendations are largely based on data from PD studies, including fludrocortisones [95,96], midodrine [95,96], and droxidopa [97] for treating orthostatic hypotension, polyethylene glycol (also known as macrogrol) [98,99] and psyllium for constipation, and the antimuscarinic solifenacin [89] and the β3-adrenoceptor agonist mirabegron [101] to treat urinary frequency, incontinence, or nocturia.
Investigational drugs for the treatment of binge eating disorder (BED): an update
Published in Expert Opinion on Investigational Drugs, 2019
Jose C. Appolinario, Antonio E. Nardi, Susan L. McElroy
Armodafinil is the R-enantiomer of the racemic modafinil approved for the treatment of excessive daytime sleepiness in narcoleptic patients. Armodafinil blocks dopamine reuptake by binding to the dopamine transporter and increasing dopamine concentrations in the brain [115]. McElroy et al. [116] assessed the effectiveness of armodafinil in a randomized placebo-controlled trial with 60 participants with BED (NCT01010789). In a primary analysis, armodafinil did not differentiate from placebo in binge eating day frequency (the primary outcome measure); however, armodafinil was associated with a statistically significantly higher rate of decrease in binge eating episode frequency, in obsessive-compulsive features of binge eating and BMI. The mean (SD) armodafinil daily dose was 216.7 (43.9) mg. Overall, the agent was well tolerated, although one armodafinil subject developed markedly increased blood pressure that resolved upon drug discontinuation. The authors commented that the small sample size may have limited the detection of important drug-placebo differences.
Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment
Published in Behavioral Sleep Medicine, 2019
Charles Kamen, Sheila N. Garland, Charles E. Heckler, Anita R. Peoples, Ian R. Kleckner, Calvin L. Cole, Michael L. Perlis, Gary R. Morrow, Karen M. Mustian, Joseph A. Roscoe
Armodafinil is a single isomer formulation of modafinil (R-enantiomer of modafinil) that is indicated for the promotion of wakefulness in several sleep disorders including narcolepsy, sleep apnea syndrome, and shift work disorder. Participants randomized to receive armodafinil were provided a 50 mg dose of armodafinil in the morning (7:00–9:00 a.m.) and a placebo in the afternoon (12:00–2:00 p.m.) for three days, followed by two 50 mg doses of armodafinil per day (morning and afternoon) for 40 days, and then finally a 50 mg dose of armodafinil in the morning and a placebo in the afternoon for another four days. Patients randomized to receive placebo were provided a placebo capsule in the morning and afternoon to mimic the dosage times of the medication group.