An interventional study of scale of severity and blood sample in Somnolence Disorder, Excessive, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-01-02.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Basic science
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Among 30 studies in Disorders of Excessive Somnolence with a site in France — 9 open to participants now, 10 under way, 4 of them phase 3. Disorders of Excessive Somnolence · France.
Among the 30 studies in Disorders of Excessive Somnolence with a site in France, this one has the largest planned enrollment of the 24 interventional ones that give a count, is the only one that started in 2020, is one of 6 with no phase, and was the 16th registered.
196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
Browse Disorders of Excessive Somnolence studies →9 of the 30 studies in Disorders of Excessive Somnolence with a site in France are open now. Recruiting first, the newest first:
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
University Hospital, Bordeaux · Sites in France
Ages 18–65 · Healthy volunteers
Alkermes, Inc. · Sites in France, United States, Australia and 5 more countries
Ages 18–70
Hospices Civils de Lyon · Sites in France
Ages 18–65
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 6 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 13
First in 2003; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5,000 is above the median of 86 across 158 interventional studies indexed under Disorders of Excessive Somnolence.
Median enrollment 130 across the 24 interventional studies, 110 across the 6 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
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9 of 30 have an industry lead sponsor. The 10 most frequent:
University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
University Hospital, Montpellier has 1 study filed under Disorders of Excessive Somnolence — fewer than ten, so there is no comparison to draw.
7 of the studies in Disorders of Excessive Somnolence with a site in France that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06366464Phase 3Harmony Biosciences Management, Inc.A Study of Pitolisant in Patients With Prader-Willi Syndrome | 2027-04 |
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT06457945Hospices Civils de LyonMind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions | 2026-12-03 |
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Among the 30 studies in Disorders of Excessive Somnolence with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Chronic sleep disorders result from multiple pathophysiological mechanisms and are often associated with severe hypersomnolence, responsible for major disability. Hypersomnolence may be secondary to sleep disturbances at night by sleep fragmentation, both overall in restless leg syndrome (RLS) or specific to slow or paradoxical sleep in parasomnias (sleepwalking, sleep behavior disorder). paradoxical). Attention-Deficit / Hyperactivity Disorder (ADHD) is another cause of secondary hypersomnolence, unsolved pathophysiology, leading to a major disturbance of alertness. More rarely, hypersomnolence may be primary (central hypersomnia), representing then the most severe form existing in humans. The best-known central hypersomnia is narcolepsy type 1 (NT1), affecting 0.02% of the population. It is thanks to the existence of well-characterized clinical, biological and neuropathological patients that its pathophysiology is better understood. It is due to a selective loss of hypothalamic neurons secreting orexin / hypocretin, in connection with a probable autoimmune process, in genetically predisposed subjects. Narcolepsy type 2 (NT2), idiopathic hypersomnia (HI) and Kleine-Levin syndrome (SKL), are rarer forms of central hypersomnia, the pathophysiology of which is still unknown, due to the small number of patients studied.
Chronic sleep disorders result from multiple pathophysiological mechanisms and are often associated with severe hypersomnolence, responsible for major disability. Hypersomnolence may be secondary to sleep disturbances at night by sleep fragmentation, both overall in restless leg syndrome (RLS) or specific to slow or paradoxical sleep in parasomnias (sleepwalking, sleep behavior disorder). paradoxical). Attention-Deficit / Hyperactivity Disorder (ADHD) is another cause of secondary hypersomnolence, unsolved pathophysiology, leading to a major disturbance of alertness. More rarely, hypersomnolence may be primary (central hypersomnia), representing then the most severe form existing in humans. The best-known central hypersomnia is narcolepsy type 1 (NT1), affecting 0.02% of the population. It is thanks to the existence of well-characterized clinical, biological and neuropathological patients that its pathophysiology is better understood. It is due to a selective loss of hypothalamic neurons secreting orexin / hypocretin, in connection with a probable autoimmune process, in genetically predisposed subjects. Narcolepsy type 2 (NT2), idiopathic hypersomnia (HI) and Kleine-Levin syndrome (SKL), are rarer forms of central hypersomnia, the pathophysiology of which is still unknown, due to the small number of patients studied.
Chronic sleep disorders result from multiple pathophysiological mechanisms and the constitution of a clinical, neurophysiological and biological cohort, monocentric. Patients (minors or adults) suffering from chronic sleep disorders responsible for hypersomnolence will be recruited, followed by the Sleep Disorders Unit (UTSE) and the National Reference Center for Rare Hypersomnia (CNRH) in Montpellier. The number of topics to include depends on feasibility criteria including the rarity of certain sleep disorders and recruitment opportunities. At a minimum, 150 subjects per group will be recruited according to the following ratio: NT1 (33%), other central hypersomnias (NT2, HI, SKL, 33%), and hypersomnolence secondary to a neurological sleep or vigilance disorder (ADHD, RLS, parasomnias, 33%). A match on age and sex will be considered
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Exclusion Criteria:
Subjects with chronic sleep disorders responsible of hypersomnolence measured by a scale of severity of sleep disorder, and blood parameters (blood sample)
Other: scale of severity · Genetic: blood sample
assessment of the severity of the sleep disorders by scale
Genetical study, serum and sample
Severity of somnolence
evaluation with sleep latency test, validated questionnaires
Time frame: Inclusion
level of somnolence
Physicians Global Assessment to measure the evolution of somnolence
Time frame: 12 months maximum
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2020 (actual). Primary completion is estimated for Jun 2030, 120 months after the start.
Of 32 non-industry interventional studies with no phase under Disorders of Excessive Somnolence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 120 months is above that.
Counting every sponsor, half of 34 studies reached it within 22 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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Disorders of Excessive Somnolence →
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