Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease
Identifieur interne : 000814 ( PascalFrancis/Curation ); précédent : 000813; suivant : 000815Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease
Auteurs : Charles H. Adler [États-Unis] ; John N. Caviness [États-Unis] ; Joseph G. Hentz [États-Unis] ; Marlene Lind [États-Unis] ; Judy Tiede [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2003.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Adulte.
English descriptors
- KwdEn :
Abstract
We assessed the safety and efficacy of modafinil for the treatment of excessive daytime sleepiness in patients with Parkinson's disease (PD). This was a single-site, randomized, double-blind, placebo-controlled crossover study of 21 PD patients having an Epworth Sleepiness Scale (ESS) score ≥ 10. They received either placebo or modafinil 200 mg/day for 3 weeks, followed by a washout week, then the alternate treatment for 3 weeks. The ESS data demonstrated a carryover effect, so the changes from baseline ESS scores were compared between the two treatments for period 1 only. The ESS scores for the placebo group went from 16.0 ± 4.2 (mean ± SD) to 17.0 ± 5.1 and for the modafinil group went from 17.8 ± 4.2 to 14.4 ± 5.7 (P = 0.039). There was no significant carryover effect for any other measure. The patient Clinical Global Impression of Change (+3 to -3) improved by 0.75 on modafinil compared with 0.15 for placebo (P = 0.07). A total of 7 of 20 (35%) of the patients reported some improvement on modafinil but not placebo. There was no significant improvement or worsening of the UPDRS subscores I-III, Timed Tap test, or time on. Vital signs, electrocardiograms, and lab tests were unchanged. Modafinil was very well tolerated. Our data demonstrate that, in a small sample size, administration of 200 mg/day of modafinil was associated with few side effects and was modestly effective for the treatment of excessive daytime sleepiness in patients with PD.
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<front><div type="abstract" xml:lang="en">We assessed the safety and efficacy of modafinil for the treatment of excessive daytime sleepiness in patients with Parkinson's disease (PD). This was a single-site, randomized, double-blind, placebo-controlled crossover study of 21 PD patients having an Epworth Sleepiness Scale (ESS) score ≥ 10. They received either placebo or modafinil 200 mg/day for 3 weeks, followed by a washout week, then the alternate treatment for 3 weeks. The ESS data demonstrated a carryover effect, so the changes from baseline ESS scores were compared between the two treatments for period 1 only. The ESS scores for the placebo group went from 16.0 ± 4.2 (mean ± SD) to 17.0 ± 5.1 and for the modafinil group went from 17.8 ± 4.2 to 14.4 ± 5.7 (P = 0.039). There was no significant carryover effect for any other measure. The patient Clinical Global Impression of Change (+3 to -3) improved by 0.75 on modafinil compared with 0.15 for placebo (P = 0.07). A total of 7 of 20 (35%) of the patients reported some improvement on modafinil but not placebo. There was no significant improvement or worsening of the UPDRS subscores I-III, Timed Tap test, or time on. Vital signs, electrocardiograms, and lab tests were unchanged. Modafinil was very well tolerated. Our data demonstrate that, in a small sample size, administration of 200 mg/day of modafinil was associated with few side effects and was modestly effective for the treatment of excessive daytime sleepiness in patients with PD.</div>
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<s5>41</s5>
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<fC07 i1="06" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Trouble sommeil</s0>
<s5>69</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Sleep disorder</s0>
<s5>69</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Trastorno sueño</s0>
<s5>69</s5>
</fC07>
<fN21><s1>146</s1>
</fN21>
<fN82><s1>PSI</s1>
</fN82>
</pA>
</standard>
</inist>
</record>
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