NarcolepsyMRM-OREXNCT05615584
Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence
A study testing Quantitative mass spectrometry assay in people with Narcolepsy and Idiopathic Hypersomnia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome. The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy
- What is being tested?
- Quantitative mass spectrometry assay
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 8 years
- Complaint of hypersomnolence and suspected central hypersomnolence
- Benefiting from a standardised assessment: clinical, biological and neurophysiological
- Lumbar puncture necessary for the assessment
- Sufficient cerebrospinal fluid taken for biological analysis (at least 1 ml)
- Signed informed consent
Who cannot join
- Contraindication to lumbar puncture
- Secondary hypersomnolence
- Refusal to participate in the study or refusal of the lumbar puncture
- Adult protected by law, or subject deprived of liberty, by judicial or administrative decision or patient under guardianship or curatorship
- Subject not affiliated to the French social security system
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Reaction Monitoring (MRM) Versus I 125 Radioimmunoassay (RIA) for the Quantification of Orexin-A/Hypocretin-1 Levels in Cerebrospinal Fluid: a Prospective Diagnostic Validation Study in Patients With Hypersomnolence
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome.
The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria.
The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy
- Being tested
- Quantitative mass spectrometry assay
- Keywords
- orexin/hypocretin, sleepiness
- Medical subject headings
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative mass spectrometry assayDiagnostic test
ORX-A determination by quantitative mass spectrometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Orexin-A dosage by Multiple Reaction Monitoring Mass Spectrometry
Multiple Reaction Monitoring mass spectrometry for orexin-A dosage in cerebrospinal fluid
Measured: Day 1 (=day of inclusion)
Orexin-A dosage by radioimmunoassay
Radioimmunoassay for orexin-A dosage in cerebrospinal fluid
Measured: Day 1
Secondary outcomes (10)
Age of onset of hypersomnia symptoms
Measured: Day 1
Frequency of cataplexy
Measured: Up to 24 hours
Characteristics of cataplexy
Measured: Up to 24 hours
Average duration of cataplexy
Measured: Up to 24 hours
Epworth sleepiness scale (ESS)
the score will be between 0 and 24, higher scores mean a worse outcome
Measured: Day 1
Narcolepsy severity scale (NSS)
the score will be between 0 and 57, higher scores mean a worse outcome
Measured: Day 1
Hypersomnolence severity scale (IHSS)
the score will be between 0 and 50, higher scores mean a worse outcome
Measured: Day 1
Insomnia severity index
the score will be between 0 and 32, higher scores mean a worse outcome
Measured: Day 1
Iterative sleep latency tests (TILE)
Measured: Up to 24 hours
Presence of the HLA allele DQB1*06:02
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Feb 2023
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615584
- Sponsor's protocol ID
- RECHMPL22_0072
- Acronym
- MRM-OREX
- Status last verified
- Jul 2026
- First submitted
- 26 Oct 2022
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Reaction Monitoring (MRM) Versus I 125 Radioimmunoassay (RIA) for the Quantification of Orexin-A/Hypocretin-1 Levels in Cerebrospinal Fluid: a Prospective Diagnostic Validation Study in Patients With Hypersomnolence
- ClinicalTrials.gov ID
- NCT05615584
- Acronym / sponsor ID
- MRM-OREX / RECHMPL22_0072
- Conditions
- Narcolepsy, Idiopathic Hypersomnia, Cataplexy
- Keywords
- orexin/hypocretin, sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In humans, selective loss of orexin neurons is responsible for type 1 narcolepsy (NT1), or narcolepsy with cataplexy, or orexin deficiency syndrome.
The International Classification of Sleep Disorders 3rd edition (ICSD-3) distinguishes between hypersomnolence of central origin: NT1, narcolepsy type 2 (NT2), or narcolepsy without cataplexy, and idiopathic hypersomnia (HI). These rare conditions are all characterised by hypersomnolence (excessive daytime sleepiness, or excessive need for sleep), which is the primary and often most disabling symptom. A level of ORX-A in cerebrospinal fluid (CSF) (<110 pg/mL) is a very sensitive and specific biomarker of NT1, currently sufficient for the diagnosis of this condition. In contrast, ORX neurons are thought to be intact in IH and NT2, and the pathophysiological mechanisms underlying these diseases remain unknown. Thus, their diagnosis is based solely on clinical and electrophysiological criteria.
The objective of this project is to determine the validity of a mass spectrometric technique for the determination of ORX-A in the cerebral spinal fluid of patients suffering from hypersomnolence in comparison with the radioimmunoassay which is the reference technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 8 years
- Complaint of hypersomnolence and suspected central hypersomnolence
- Benefiting from a standardised assessment: clinical, biological and neurophysiological
- Lumbar puncture necessary for the assessment
- Sufficient cerebrospinal fluid taken for biological analysis (at least 1 ml)
Key exclusion criteria (6 listed)
- Contraindication to lumbar puncture
- Secondary hypersomnolence
- Refusal to participate in the study or refusal of the lumbar puncture
- Adult protected by law, or subject deprived of liberty, by judicial or administrative decision or patient under guardianship or curatorship
- Subject not affiliated to the French social security system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative mass spectrometry assayORX-A determination by quantitative mass spectrometry | Diagnostic test | – |
Primary outcome
Orexin-A dosage by Multiple Reaction Monitoring Mass Spectrometry
Time frame: Day 1 (=day of inclusion)
Multiple Reaction Monitoring mass spectrometry for orexin-A dosage in cerebrospinal fluid
Orexin-A dosage by radioimmunoassay
Time frame: Day 1
Radioimmunoassay for orexin-A dosage in cerebrospinal fluid
10 secondary outcomes
Age of onset of hypersomnia symptoms
Time frame: Day 1
Frequency of cataplexy
Time frame: Up to 24 hours
Characteristics of cataplexy
Time frame: Up to 24 hours
Average duration of cataplexy
Time frame: Up to 24 hours
Epworth sleepiness scale (ESS)
Time frame: Day 1
Narcolepsy severity scale (NSS)
Time frame: Day 1
Hypersomnolence severity scale (IHSS)
Time frame: Day 1
Insomnia severity index
Time frame: Day 1
Iterative sleep latency tests (TILE)
Time frame: Up to 24 hours
Presence of the HLA allele DQB1*06:02
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative mass spectrometry assay in people with Narcolepsy and Idiopathic Hypersomnia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orexin-A dosage by Multiple Reaction Monitoring Mass Spectrometry (time frame: Day 1 (=day of inclusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.