An observational study in Narcolepsy Type 1, Narcolepsy Type 2 and Narcolepsy and Hypersomnia, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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Among 49 studies in Narcolepsy with a site in France — 12 open to participants now, 13 under way, 5 of them phase 3. Narcolepsy · France.
Among the 49 studies in Narcolepsy with a site in France, this one is the 2nd largest by planned enrollment of the 11 observational ones that give a count, is one of 6 that started in 2026, is one of 11 observational ones, reaches primary completion later than 12 of the 12 other live ones, and was the 49th registered.
158 studies on the registry are indexed under Narcolepsy; 38 are open to participants now.
Browse Narcolepsy studies →12 of the 49 studies in Narcolepsy with a site in France are open now. Recruiting first, the newest first:
Takeda · Sites in France, United States, Australia and 4 more countries
Ages 18–70
Harmony Biosciences Management, Inc. · Sites in France, United States, Belgium and 4 more countries
Ages 18+
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
Takeda · Sites in France, United States, China and 4 more countries
Ages 18–70
Centre Hospitalier Universitaire de Nīmes · Sites in France
Ages 10+ · Healthy volunteers
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 Narcolepsy studies recruiting now, 12 (40%) set no upper age limit and 16 (53%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
49 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 11 · Phase 3 18 · Phase 4 1
First in 2003; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,500 is above the median of 149 across 39 observational studies indexed under Narcolepsy.
Median enrollment 104 across the 38 interventional studies, 120 across the 11 observational. Of the 34 that completed or were terminated, 16 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 49 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 2 studies filed under Narcolepsy — fewer than ten, so there is no comparison to draw.
7 of the studies in Narcolepsy 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 |
|---|---|
| NCT07363720Phase 3TakedaA Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy | 2026-12-17 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07675135Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy | 2027-10 |
| NCT06952699TakedaA Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) | 2026-11-30 |
| NCT05773872Centre Hospitalier Universitaire, AmiensEvaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia | 2027-05 |
Add all 7 to your calendar (.ics) → With an account.
Among the 49 studies in Narcolepsy with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Central hypersomnias are rare diseases that include narcolepsy and idiopathic hypersomnia.
The Sleep and Vigilance Center at Hôtel-Dieu has been certified as a Rare Disease Reference Center (CRMR) for these conditions since 2005.
Scientific advances and changes to the ICSD (International Classification of Sleep Disorders) since 2005 (diagnostic criteria and drugs brought to market) have greatly improved the care of patients with central hypersomnia.
This retrospective and prospective study aims to evaluate how each advance translates into concrete terms in the care of patients followed at our center.
Main objective :
Determine whether new treatments are prescribed to replace treatments already on the market (reduction in prescriptions for treatments previously marketed) or whether they enable patients who have reached a therapeutic impasse to be treated (no reduction in prescriptions for treatments previously marketed).
Central hypersomnias are rare diseases that include narcolepsy and idiopathic hypersomnia.
The Sleep and Vigilance Center at Hôtel-Dieu has been certified as a Rare Disease Reference Center (CRMR) for these conditions since 2005.
Scientific advances and changes to the ICSD (International Classification of Sleep Disorders) since 2005 (diagnostic criteria and drugs brought to market) have greatly improved the care of patients with central hypersomnia.
This retrospective and prospective study aims to evaluate how each advance translates into concrete terms in the care of patients followed at our center.
Main objective :
Determine whether new treatments are prescribed to replace treatments already on the market (reduction in prescriptions for treatments previously marketed) or whether they enable patients who have reached a therapeutic impasse to be treated (no reduction in prescriptions for treatments previously marketed).
Patients diagnosed with central hypersomnia and diagnosed and/or followed-up at our site.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients diagnosed with central hypersomnia
Other: Non applicable
Non applicable
Ratio of the number of patients who were prescribed this treatment during the year to the number of patients who had at least one consultation at the center during the same year.
Ratio of the number of patients who were prescribed this treatment during the year to the number of patients who had at least one consultation at the center during the same year. Annual change in prescriptions for each treatment
Time frame: For the 1st time for prescriptions from Jan 1, 2005, to Dec 31, 2025. Then, every three years: prescriptions until Dec 31, 2028, Dec 31, 2031, and Dec 31, 2034, in order to take into account marketing of new treatments currently in phase 3
Number of days of treatment
Number of days of treatment: mean + standard deviation for patients who received this treatment during the year, median and quartiles. Annual change in prescriptions for each treatment
Time frame: For the 1st time for prescriptions from Jan 1, 2005, to Dec 31, 2025. Then, every three years: prescriptions until Dec 31, 2028, Dec 31, 2031, and Dec 31, 2034, in order to take into account marketing of new treatments currently in phase 3
Annual percentage of patients taking at least two treatments for their central hypersomnia.
Annual percentage of patients taking at least two treatments for their central hypersomnia.
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Number of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
Number of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
Time frame: During first analyses
Percentage of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
Percentage of diagnoses made between 2005 and 2023 that were modified by the new ICSD criteria in 2023.
Time frame: During first analyses
Number of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
Number of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Percentage of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
Percentage of patients with an initial diagnosis of NT2 who were reclassified as NT1 due to the onset of cataplexy.
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Epworth scale
Reduction in sleepiness (Epworth scale and wakefulness maintenance tests) average for each treatment and combination of treatments.
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Wakefulness maintenance tests
Reduction in sleepiness (Epworth scale and wakefulness maintenance tests) average for each treatment and combination of treatments.
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Average age of these patients at the onset of cataplexy
Average age of these patients at the onset of cataplexy
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Average number of years between initial diagnosis and onset of cataplexy
Average number of years between initial diagnosis and onset of cataplexy
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Average number of years between first symptoms and onset of cataplexy.
Average number of years between first symptoms and onset of cataplexy.
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Adverse events collected during medical consultations
Adverse events collected during medical consultations
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Effects on other components of the pathologies
Effects on other components of the pathologies (via IHSS scores, NSS, fatigue and brain fog scale, etc.).
Time frame: This criterion will be assessed for the first time for prescriptions from January 1, 2005, to December 31, 2025. Then, every 3 years: prescriptions until December 31, 2028, December 31, 2031, and December 31, 2034.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2036, 120 months later.
Of 19 observational studies under Narcolepsy, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 73. This study's planned 120 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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