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PROVIGIL (MODAFINIL): CLINICAL TRIALS FOR OBSTRUCTIVE SLEEP APNEA (OSA)
Obstructive Sleep Apnea (OSA)
The effectiveness of Provigil (Modafinil) in reducing the excessive sleepiness associated with OSA was established in two clinical trials. In both studies, patients were enrolled who met the International Classification of Sleep Disorders (ICSD) criteria for OSA (which are also consistent with the American Psychiatric Association DSM-IV criteria). These criteria include either, 1) excessive sleepiness or insomnia, plus frequent episodes of impaired breathing during sleep, and associated features such as loud snoring, morning headaches and dry mouth upon awakening; or 2) excessive sleepiness or insomnia and polysomnography demonstrating one of the following: more than five obstructive apneas, each greater than 10 seconds in duration, per hour of sleep and one or more of the following: frequent arousals from sleep associated with the apneas, bradytachycardia, and arterial oxygen desaturation in association with the apneas. In addition, for entry into these studies, all patients were required to have excessive sleepiness as demonstrated by a score >= 10 on the Epworth Sleepiness Scale, despite treatment with continuous positive airway pressure (CPAP). Evidence that CPAP was effective in reducing episodes of apnea/hypopnea was required along with documentation of CPAP use.
In the first study, a 12-week multicenter placebo-controlled trial, a total of 327 patients were randomized to receive PRovigil 200 mg/day, Provigil 400 mg/day, or matching placebo. The majority of patients (80%) were fully compliant with CPAP, defined as CPAP use > 4 hours/night on > 70% nights. The remainder were partially CPAP compliant, defined as CPAP use < 4 hours/night on > 30% nights. CPAP use continued throughout the study. The primary measures of effectiveness were 1) sleep latency, as assessed by the Maintenance of Wakefulness Test (MWT) and 2) the change in the patient's overall disease status, as measured by the Clinical Global Impression of Change (CGI-C) at week 12 or the final visit.
Patients treated with Provigil (Modafinil) tablets showed a statistically significant improvement in the ability to remain awake compared to placebo-treated patients as measured by the MWT (p < 0.001) at endpoint. Provigil-treated patients also showed a statistically significant improvement in clinical condition as rated by the CGI-C scale (p < 0.001). The two doses of Modafinil (Provigil) performed similarly.
In the second study, a 4-week multicenter placebo-controlled trial, 157 patients were randomized to either Provigil 400 mg/day or placebo. Documentation of regular CPAP use (at least 4 hours/night on 70% of nights) was required for all patients. The primary outcome measure was the change from baseline on the ESS at week 4 or final visit. The baseline ESS scores for the Provigil and placebo groups were 14.2 and 14.4, respectively. At week 4, the ESS was reduced by 4.6 in the Provigil group and by 2.0 in the placebo group, a difference that was statistically significant (p < 0.0001).
Nighttime sleep measured with polysomnography was not affected by the use of Modafinil (Provigil) tablets.
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