Unité Inserm 1061 Neuropsychiatrie : Recherche épidémiologique et clinique
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How can the quality of life of patients with narcolepsy, the severest sleep disorder in humans, be improved? An international scientific team led by Yves Dauvilliers, a researcher at Inserm and Université de Montpellier, is working on Solriamfetol – a promising new drug that stimulates alertness and improves resistance to sleepiness. The results of the Phase 3 clinical trial published in Annals of Neurology show that when compared with existing treatments, Solriamfetol is not just more effective and long-lasting, but also has fewer side effects.
Narcolepsy is a chronic rare neurological disorder caused by a loss of neurons that synthesize the protein hypocretin. It is characterized by excessive daytime sleepiness and difficulty staying awake. Being the severest sleep disorder in humans, it is an excellent model for studying other pathologies of the same type.
It is on the development of a more effective drug in improving narcolepsy symptoms that is working Yves Dauvilliers, researcher at Inserm and Université de Montpellier in the “Neuropsychiatry: Epidemiological and Clinical Research” laboratory (Inserm/Université de Montpellier), in collaboration with international teams. The research he is leading is centered around Solriamfetol, a drug that not only inhibits the transporters of dopamine but also those of norepinephrine – another neurotransmitter involved in the regulation of waking.
In this Phase 3 clinical trial, 240 narcoleptic patients were followed for 12 weeks in order to evaluate the efficacy and safety of Solriamfetol in humans. The tests were performed under double-blind conditions on groups of 60 patients receiving different doses of Solriamfetol or placebo. In addition to patient feedback on the day-to-day changes in their sleepiness, the trial also involved tests in which the patients were required to try to stay awake in an atmosphere conducive to sleep.
The research team observed that those patients receiving a daily dose of 150 mg or 300 mg Solriamfetol managed to fight sleepiness for around 20 minutes versus 10 without treatment, i.e. for twice as long. The currently-prescribed treatments extend this alertness by only 2 to 3 minutes. This efficacy was maintained throughout the 12 weeks of treatment, with few side effects and no need to increase dosage.
The study protocol was developed, in collaboration with the authors, by Jazz Pharmaceuticals, which is funding the trial and holds a license to develop and commercialize Solriamfetol
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A Randomized Study of Solriamfetol for Excessive Sleepiness in Narcolepsy
Michael J. Thorpy, MB, ChB,1 Colin Shapiro, MBBCh, PhD,2 Geert Mayer, MD,3 Bruce C. Corser, MD,4 Helene Emsellem, MD,5 Giuseppe Plazzi, MD,6,7 Dan Chen, MD, PhD,8 Lawrence P. Carter, PhD,8,9 Hao Wang, PhD,10 Yuan Lu, MS,9 Jed Black, MD,8,11 and Yves Dauvilliers, MD, PhD12
1 Sleep-Wake Disorders Center, Montefiore Medical Center, Bronx, NY;
2 Department of Psychiatry, Sleep and Alertness Clinic, Sleep Research Laboratory, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada;
3 Sleep Disorder Unit, Hephata Clinic, Schwalmstadt, Germany;
4 Sleep Management Institute, Cincinnati, OH;
5 Center for Sleep and Wake Disorders, Chevy Chase, MD;
6 Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy;
7 Scientific Institute of Hospitalization and Care, Bologna Institute of Neurological Sciences, Bologna, Italy;
8 Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA;
9 Department of Pharmacology and Toxicology, University of Arkansas for Medical Sciences, Little Rock, AR;
10 Biostatistics, Jazz Pharmaceuticals, Palo Alto, CA;
11 Stanford Center for Sleep Science and Medicine, Redwood City, CA; and
12 Reference National Center for Narcolepsy-Hypersomnia, Guy de Chauliac Hospital, Montpellier University Hospital Center, National Institute of Health and Medical Research U1061, Montpellier, France
Annals of Neurology : https://doi.org/10.1002/ana.25423