MovDisordV3, Main, Exploration, bibRecordById, Pascal:03-0239366

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

Identifieur interne : 003F72 ( Main/Exploration ); précédent : 003F71; suivant : 003F73

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 :

Movement Disorders [ 0885-3185 ] ; 2003-03.

RBID : ISTEX:1111DB3FB845840AFB3BB37CF3F06199532D6240

Descripteurs français

Pascal (Inist)
- Adulte, Chimiothérapie, Complication, Etude double insu, Modafinil, Parkinson maladie, Psychotrope, Randomisation, Sommeil diurne, Somnolence, Stimulant SNC, Toxicité, Traitement.
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:

https://api.istex.fr/document/1111DB3FB845840AFB3BB37CF3F06199532D6240/fulltext/pdf

DOI: 10.1002/mds.10390

Affiliations:

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<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>
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<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>
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<term>Central Nervous System Stimulants</term>
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<term>Central Nervous System Stimulants</term>
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<term>Aged</term>
<term>Cross-Over Studies</term>
<term>Double-Blind Method</term>
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<term>Humans</term>
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<term>Etude double insu</term>
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<term>Parkinson maladie</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>
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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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Movement Disorders (revue)

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

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

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

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Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

	Movement Disorders (revue)
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