Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease
Identifieur interne : 003F72 ( Main/Exploration ); précédent : 003F71; suivant : 003F73Randomized 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 ] ; 2003-03.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Adulte.
English descriptors
- KwdEn :
- Adult, Aged, Benzhydryl Compounds (adverse effects), Benzhydryl Compounds (therapeutic use), CNS stimulant, Central Nervous System Stimulants (adverse effects), Central Nervous System Stimulants (therapeutic use), Chemotherapy, Complication, Cross-Over Studies, Day sleep, Disorders of Excessive Somnolence (complications), Disorders of Excessive Somnolence (diagnosis), Disorders of Excessive Somnolence (drug therapy), Double blind study, Double-Blind Method, Female, Humans, Male, Modafinil, Parkinson Disease (complications), Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Psychiatric Status Rating Scales, Psychotropic, Randomization, Severity of Illness Index, Somnolence, Toxicity, Treatment, Treatment Outcome, Wakefulness (drug effects), excessive daytime sleepiness, modafinil.
- MESH :
- chemical , adverse effects : Benzhydryl Compounds, Central Nervous System Stimulants.
- chemical , therapeutic use : Benzhydryl Compounds, Central Nervous System Stimulants.
- complications : Disorders of Excessive Somnolence, Parkinson Disease.
- diagnosis : Disorders of Excessive Somnolence.
- drug effects : Wakefulness.
- drug therapy : Disorders of Excessive Somnolence, Parkinson Disease.
- Adult, Aged, Cross-Over Studies, Double-Blind Method, Female, Humans, Male, Psychiatric Status Rating Scales, Severity of Illness Index, Treatment Outcome.
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.
Url:
DOI: 10.1002/mds.10390
Affiliations:
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Le document en format XML
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<term>Aged</term>
<term>Benzhydryl Compounds (adverse effects)</term>
<term>Benzhydryl Compounds (therapeutic use)</term>
<term>CNS stimulant</term>
<term>Central Nervous System Stimulants (adverse effects)</term>
<term>Central Nervous System Stimulants (therapeutic use)</term>
<term>Chemotherapy</term>
<term>Complication</term>
<term>Cross-Over Studies</term>
<term>Day sleep</term>
<term>Disorders of Excessive Somnolence (complications)</term>
<term>Disorders of Excessive Somnolence (diagnosis)</term>
<term>Disorders of Excessive Somnolence (drug therapy)</term>
<term>Double blind study</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Modafinil</term>
<term>Parkinson Disease (complications)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson disease</term>
<term>Parkinson's disease</term>
<term>Psychiatric Status Rating Scales</term>
<term>Psychotropic</term>
<term>Randomization</term>
<term>Severity of Illness Index</term>
<term>Somnolence</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Treatment Outcome</term>
<term>Wakefulness (drug effects)</term>
<term>excessive daytime sleepiness</term>
<term>modafinil</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Benzhydryl Compounds</term>
<term>Central Nervous System Stimulants</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Benzhydryl Compounds</term>
<term>Central Nervous System Stimulants</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Disorders of Excessive Somnolence</term>
<term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Disorders of Excessive Somnolence</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Wakefulness</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Disorders of Excessive Somnolence</term>
<term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Cross-Over Studies</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Psychiatric Status Rating Scales</term>
<term>Severity of Illness Index</term>
<term>Treatment Outcome</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Adulte</term>
<term>Chimiothérapie</term>
<term>Complication</term>
<term>Etude double insu</term>
<term>Modafinil</term>
<term>Parkinson maladie</term>
<term>Psychotrope</term>
<term>Randomisation</term>
<term>Sommeil diurne</term>
<term>Somnolence</term>
<term>Stimulant SNC</term>
<term>Toxicité</term>
<term>Traitement</term>
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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>
</front>
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<affiliations><list><country><li>États-Unis</li>
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<region><li>Arizona</li>
</region>
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<tree><country name="États-Unis"><region name="Arizona"><name sortKey="Adler, Charles H" sort="Adler, Charles H" uniqKey="Adler C" first="Charles H." last="Adler">Charles H. Adler</name>
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<name sortKey="Caviness, John N" sort="Caviness, John N" uniqKey="Caviness J" first="John N." last="Caviness">John N. Caviness</name>
<name sortKey="Hentz, Joseph G" sort="Hentz, Joseph G" uniqKey="Hentz J" first="Joseph G." last="Hentz">Joseph G. Hentz</name>
<name sortKey="Lind, Marlene" sort="Lind, Marlene" uniqKey="Lind M" first="Marlene" last="Lind">Marlene Lind</name>
<name sortKey="Tiede, Judy" sort="Tiede, Judy" uniqKey="Tiede J" first="Judy" last="Tiede">Judy Tiede</name>
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