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Movement Disorders (revue)

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Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease

Identifieur interne : 000814 ( PascalFrancis/Curation ); précédent : 000813; suivant : 000815

Randomized 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 :

RBID : Pascal:03-0239366

Descripteurs français

English descriptors

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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A08 01  1  ENG  @1 Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease
A11 01  1    @1 ADLER (Charles H.)
A11 02  1    @1 CAVINESS (John N.)
A11 03  1    @1 HENTZ (Joseph G.)
A11 04  1    @1 LIND (Marlene)
A11 05  1    @1 TIEDE (Judy)
A14 01      @1 Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic Scottsdale @2 Scottsdale, Arizona @3 USA @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 4 aut. @Z 5 aut.
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C01 01    ENG  @0 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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C03 11  X  FRE  @0 Complication @5 18
C03 11  X  ENG  @0 Complication @5 18
C03 11  X  SPA  @0 Complicación @5 18
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C07 07  X  SPA  @0 Trastorno sueño @5 69
N21       @1 146
N82       @1 PSI

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Pascal:03-0239366

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<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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<s0>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.</s0>
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<s5>04</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Chimiothérapie</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Chemotherapy</s0>
<s5>05</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Quimioterapia</s0>
<s5>05</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Stimulant SNC</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>CNS stimulant</s0>
<s5>06</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Estimulante SNC</s0>
<s5>06</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Randomisation</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Randomization</s0>
<s5>07</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Aleatorización</s0>
<s5>07</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Etude double insu</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Double blind study</s0>
<s5>08</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Estudio doble ciego</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Psychotrope</s0>
<s2>FX</s2>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Psychotropic</s0>
<s2>FX</s2>
<s5>10</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Psicotropo</s0>
<s2>FX</s2>
<s5>10</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Somnolence</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Somnolence</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Somnolencia</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Sommeil diurne</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Day sleep</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Sueño diurno</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>17</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>17</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE">
<s0>Complication</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG">
<s0>Complication</s0>
<s5>18</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA">
<s0>Complicación</s0>
<s5>18</s5>
</fC03>
<fC03 i1="12" i2="X" l="FRE">
<s0>Toxicité</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="ENG">
<s0>Toxicity</s0>
<s5>19</s5>
</fC03>
<fC03 i1="12" i2="X" l="SPA">
<s0>Toxicidad</s0>
<s5>19</s5>
</fC03>
<fC03 i1="13" i2="X" l="FRE">
<s0>Adulte</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="ENG">
<s0>Adult</s0>
<s5>20</s5>
</fC03>
<fC03 i1="13" i2="X" l="SPA">
<s0>Adulto</s0>
<s5>20</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Homme</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Human</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Hombre</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Système nerveux pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Système nerveux central pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Encéphale pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Cerebral disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Encéfalo patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Extrapyramidal syndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Extrapyramidal syndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Extrapiramidal síndrome</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Maladie dégénérative</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Degenerative disease</s0>
<s5>41</s5>
</fC07>
<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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