An interventional study of 7T MRI in Narcolepsy Type 1, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic
Among 47 studies in Narcolepsy with a site in France — 10 open to participants now, 11 under way, 4 of them phase 3. Narcolepsy · France.
Among the 47 studies in Narcolepsy with a site in France, this one is the 34th largest by enrollment of the 37 interventional ones, is one of 7 that started in 2024, is one of 10 with no phase, and was the 32nd registered.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's enrollment of 30 is below the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →10 of the 47 studies in Narcolepsy with a site in France are open now, in 12 countries. Each count lists the studies.
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 · healthy volunteers too.
The full table on the hub →47 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 7 started in 2024.
Median enrollment 102 across the 37 interventional studies, 120 across the 10 observational. Of the 34 that completed or were terminated, 16 (47%) have results posted.
23 of 47 have an industry lead sponsor. The 10 most frequent:
Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
Assistance Publique Hopitaux De Marseille has 1 study filed under Narcolepsy — fewer than ten, so there is no comparison to draw.
6 of the studies in Narcolepsy with a site in France that are under way reach primary completion within a year, 2 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 |
| 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 |
| NCT06292598Centre Hospitalier Universitaire de NīmesBacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population | 2027-09 |
Among the 47 studies in Narcolepsy with a site in France, from their registry updates:
This study is part of the research on type 1 narcolepsy, a neurological pathology affecting mostly young subjects. The only biomarker currently available is the hypocretin assay, which shows a level below 110 pg/mL. However, the interpretation of this biomarker has limitations: the test is not widely available and it is rarely performed by practitioners. Even when performed, the interpretation of the level may not be consistent with the phenotype compatible with type 1 narcolepsy.
This study therefore aims to develop new tools to reduce the diagnostic delay. This would be the first study with 7T MRI that could achieve a level of spatial resolution sufficient to highlight volume changes in small brain structures such as the lateral hypothalamus whose narcolepsy-induced changes are not detected by lower resolution MRI.
Inclusion Criteria for patients :
Exclusion Criteria for patient:
Inclusion criteria for healthy volunteers:
Exclusion criteria for healthy volunteers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with type 1 narcolepsy
Other: 7T MRI
Other: 7T MRI
Patients and healthy volunteers will have a 7T MRI
Hypothalamic morphological difference
Significant structural size difference between right and left lateral hypothalamus
Time frame: Month 0
Microstructural abnormalities other than volume differences
Significant difference in Diffusion and T2\* values in the lateral hypothalamus
Time frame: Month 0
Structural changes in hypothalamic nuclei other than the lateral hypothalamus
Significant difference in volumes and T1 values in other regions of the posterior hypothalamus
Time frame: Month 0
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Jan 2026, 23 months.
Of 21 interventional studies with no phase under Narcolepsy, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's 23 months is close to 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 completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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