Evidence map›Paper›PMID 19220275›Full record

Trial reportBritish journal of clinical pharmacology2009

Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects.

Joëlle Micallef, Marc Rey, Alexandre Eusebio, Christine Audebert, Frank Rouby, Elisabeth Jouve, Sophie Tardieu, Oliver Blin

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 60 citations in OpenAlex.

  1. Trial
  2. Article
  3. Anticholinergic burden and revisit risk in frail patients with pharmacological sleepiness.European journal of hospital pharmacy : science and practice · 2024
    Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Medications and impaired driving.The Annals of pharmacotherapy · 2014
    Review
  12. Dopaminergic role in regulating neurophysiological markers of sleep homeostasis in humans.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2014
    Article
  13. Daytime alertness in Parkinson's disease: potentially dose-dependent, divergent effects by drug class.Movement disorders : official journal of the Movement Disorder Society · 2012
    Article
  14. Article
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Joëlle MicallefClinical Investigation Centre (CIC-UPCET) and Department of Clinical Pharmacology, UMR-CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone, Marseille, France.
Marc Rey
Alexandre Eusebio
Christine Audebert
Frank Rouby
Elisabeth Jouve
Sophie Tardieu
Oliver Blin
Institut des Sciences Cognitives Marc Jeannerod · FRCentre National de la Recherche Scientifique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.

methodsPlacebo, bromocriptine (2.5 mg), L-dopa (100 mg) and pramipexole (0.5 mg) were administered in a single oral dose on four separate days, with at least a 2-week wash-out period in a randomized cross-over design. Induced somnolence was assessed using Multiple Sleep Latency Test (MSLT) and subjective scaling of vigilance. Twelve male subjects (26.3 +/- 5.5 years old) without anxiety, mood, sleep or sedation disorders were enrolled.

resultsPramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [-6.1 min (-9.8, -2.4), P = 0.002] and 5 h 30 min [-5.6 min (-7.7, -3.5), P = 0.003] after administration. In addition, the total duration of sleep during the tests was higher with pramipexole than with placebo [+6.0 min (2.3, 9.7), P < 0.001]. These differences were not observed with L-dopa and bromocriptine in comparison with placebo. The induced sleepiness was not associated with an increase in subjective somnolence scaling, indicating that this adverse event may occur without prior warning.

conclusionsThese results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.

Indexed as

AdolescentAdultAntiparkinson AgentsBenzothiazolesBromocriptineCross-Over StudiesDouble-Blind MethodHumansLevodopaMaleMiddle AgedParkinson DiseasePolysomnographyPramipexoleSleep Wake DisordersTreatment OutcomeAntiparkinson AgentsBenzothiazolesBromocriptineLevodopaPramipexole

Identifiers

PMID19220275
PMCPMC2675044
OpenAlexW2070537156

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.