Idiopathic HypersomniaPhase 2SOLR-IHNCT06590662
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
A Phase 2 study testing Solriamfetol in people with Idiopathic Hypersomnia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- Solriamfetol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2024to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Main inclusion criteria:
- Age between 18 and 60 years-old
- BMI between 18 and 30 kg/m2
- Diagnostic of idiopathic hypersomnia (ICSD-3 criteria) made in the last 5 years, based on Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, showing either: a mean sleep latency (MSL) of ≤8 minutes and < 2 SOREMPs and/or a 24-h long term polysomnography recording showing total sleep time >11h/24 hours.
- Apnea-hypopnea index (AHI) <15/hour, Apnea index <10/hour, micro-arousals index <15/hour, Periodic limb movement (PLM) index associated with micro-arousals <15/hour on the PSG and MSLT performed within the past 5 years.
- Absence of sleep deprivation, assessed by actigraphy or sleep logs for the 7 days preceding study inclusion
- ESS score ≥11 points
- Written informed consent
- National health insurance coverage
- Understand, read and speaks French well
- The participant agrees to follow the contraceptive requirements detailed in the protocol.
Main non-inclusion criteria
- Non-stabilized hypertension
- To be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening, or has positive answers on items number 4 or 5 on the Colombia-Suicide Severity Rating Scale (based on the 6 months before randomization).
- Other psychiatric conditions in the past 6 months
- Presence of other central nervous system diseases: neurodegenerative diseases, seizure disorders, or history of head trauma associated with loss of consciousness
- Prior history of psychotic episodes
- Psychostimulant treatment with modafinil, methylphenidate, mazindol, pitolisant, ongoing or within 15 days prior to visit 1
- Treatment for obstructive sleep apnea-hypopnea syndrome ongoing or within 15 days prior to visit 1
- Treatment with psychotropic drugs: neuroleptics (i.e. clozapine, olanzapine, aripiprazole, …), sedative hypnotics (benzodiazepines, zolpidem, zopiclone), central nervous system depressants (barbiturates, …), antidepressants (SSRI (e.g. fluoxetine, sertraline, paroxetine…), serotonin and norepinephrine reuptake inhibitors (SRNI : e.g. venlafaxine, duloxetine), Monoamine oxidase inhibitors), anxiolytic drugs, anticonvulsive therapy (i.e. topiramate, inhibitors of GHB dehydrogenase (i.e. valproate, ethosuximide, phenytoin), or drugs for pain (level 2 (e.g. codeine, tramadol), and level 3 (morphine and derivatives)), ongoing or within 30 days prior to visit 1.
- Treatment with dopamine antagonist antiemetics except domperidone, Catechol-O-methyltransferase (COMT) inhibitors, or sedative antihistamines ongoing or within 30 days prior to visit 1 => Of note, for all the above treatments: if patient has received such therapy, a washout-period of at least 15 days, or equivalent to 5 half-lives of the drug, prior to the inclusion in the study is required before starting treatment in this study. Of note, for antidepressants, a washout of at least 30 days should be required.
- Previously treated with solriamfetol
- History of chronic alcohol or drug abuse within the prior 12 months
- Malignant neoplastic disease requiring therapy within 12 months prior to Visit 1 or clinically relevant
- Heart failure, unstable hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study
- Renal or hepatic impairment
- No regular sleep at night: shift work or other continuous non-disease-related life conditions
- Has received any other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening or plans to use an investigational drug (other than the study intervention) during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.
Patients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).
- Conditions
- Idiopathic Hypersomnia
- Being tested
- Solriamfetol, Placebo
- Keywords
- Idiopathic hypersomnia, Solriamfetol, polysomnography
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolriamfetolDrug
Patient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. For the experimental arm, the dose will be progressively increased beginning at 75 mg to 300 mg according to tolerance to treatment.
Solriamfetol will be taken once a day upon awakening Schema of dispensation
- One tablet of solriamfetol 75 mg per day for 1 week (week 1)
- 150 mg of solriamfetol per day for 2 weeks (weeks 2 and 3)
- According clinical judgment, Dose either maintained stable at 150 mg or increased to 300 mg per day for 2 weeks (weeks 4 and 5).
- Prescription at week 5: Dose maintained at 150 or 300 mg or reduced at 150 mg per day according to benefit and safety for 2 weeks.
Treatment duration: 7 weeks treatment period.
PlaceboDrug
Patient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period.
Placebo will be taken once a day upon awakening Schema of dispensation
- One tablet of placebo per day for 1 week (week 1)
- Two tablets of placebo per day for 2 weeks (weeks 2 and 3)
- According clinical judgment, Either maintained stable with 2 tablets or increased to 4 tablets per day for 2 weeks (weeks 4 and 5).
- Prescription at week 5: Dose maintained at 2 or 4 tablets or reduced at 2 tablets per day according to benefit and safety for 2 weeks.
Treatment duration: 7 weeks placebo period.
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol | Experimental | Solriamfetol will be taken once a day upon awakening during 7-weeks Receives: Drug: Solriamfetol |
| Placebo | Placebo comparator | Placebo will be taken once a day upon awakening during 7-weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Idiopathic hypersomnia severity scale (IHSS) score
IHSS is a tool used to measure the severity of the symptoms experienced by patients with IH during the previous month. The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10-14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and 8 items on a 4-point Likert scale; the Likert scale is a point scale that is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0-50), and higher scores indicate more severe symptoms.
Measured: From baseline to week 7
Secondary outcomes (14)
Epworth Sleepiness Scale (ESS) score
ESS is a short 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Measured: From baseline to week 7
Maintenance of Wakefulness Test (MWT)
MWT is used in this study to assess an individual's ability to maintain awake while resisting the pressure to fall asleep. Patients will be administrated four 40-minute MWT session at 2 hours interval at baseline visit 2 (Day 14) and at endpoint visit (Day 35), according to validated standard. The changes in MWT will be compared between the treatment groups.
Measured: From baseline to week 7
Psychomotor vigilance task (PVT)
PVT is a widely utilized as a measure of behavioral alertness, primary due to its high sensitivity to sleep deprivation and its psychometric advantages over other cognitive tests. The standard 10-min PVT measures sustained or vigilant attention by recording response times (RT) to visual (or auditory) stimuli presented at random inter-stimulus intervals.
Measured: From baseline to week 7
Karolinska Sleepiness Scale (KSS)
KSS measures the subjective level of sleepiness at a particular time during the day. On this scale subjects indicate which level best reflects the psycho-physical sate experienced in the last 10 min. The KSS is a measure of situational sleepiness.
Measured: From baseline to week 7
Sleep inertia questionnaire
The Sleep inertia questionnaire evaluated self-reported sleep inertia and sleep drunkenness on the day of the PVT assessment, utilizing wording similar to items from IHSS scale to assess their presence and duration.
Measured: From baseline to week 7
Clinical Global Impression Scale for Change (CGI-C)
CGI-C was used to measure, the change in excessive daytime sleepiness (EDS) compared to baseline. This scale if administrated by the same investigator and consists of a 7-grade scale as follows: "very much improved", "much improved", "minimally improved", "no change", "minimally worse," "much worse", "very much worse".
Measured: From baseline to week 7
Clinical Global Impression Scale for Severity (CGI-S)
CGI-S is an observer-rated scale that measures illness severity by using a 7- grade scale ranging from ("normal, not at all ill") "borderline ill", "slightly ill", "moderately ill", "markedly ill", "severely ill", "among the most extremely ill patients".
Measured: From baseline to week 7
The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L)
EQ-5D-3L is a validated generic quality of life questionnaire that can be completed by the patient and/or caregiver and assesses 5 dimensions: mobility, washing and dressing, daily living activities, discomfort/pain, and anxiety. Each question has 3 response levels: no problem, some problems and important problems. The questionnaire includes also a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Measured: From baseline to week 7
Work Productivity and Activity Impairment- General Health (WPAI:GH)
WPAI:GH is a well validated instrument to measure the effect of health conditions on work productivity and daily activities. The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS).
Measured: From baseline to week 7
Questionnaire on Functional Outcomes of Sleep
FOSQ consists of 10 questions related to the effects of fatigue on daily activities. Each item in the FOSQ is rated on a 4 to 6-point scale, where patients provide their level of agreement of frequency of occurrence specific statements to their functioning.
Measured: From baseline to week 7
Logbook for compliance to monitor
The patient logbook must be completed throughout the treatment to monitor compliance with treatment.
Measured: From baseline to week 7
Percentage of sleep stages
% of time spent in stage 1 and 2 sleep stages and stage 3 during polysomnography
Measured: From baseline to week 7
Microarousal index
Microarousal index is apneas + hypopneas per hour of sleep during polysomnography assessment. When the respiratory event index (apneas + hypopneas per hour of sleep) is between 5 and 15 per hour of sleep, SAS is considered mild, and between 15 and 30, moderate. Above 30, it is severe.
Measured: From baseline to 7 weeks
Total sleep time
Total sleep time measured in minutes during polysomnography
Measured: From baseline to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypersomniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves DAUVILLIERS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590662
- Sponsor's protocol ID
- RECHMPL23_0432
- Acronym
- SOLR-IH
- Status last verified
- Sep 2024
- First submitted
- 6 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
- ClinicalTrials.gov ID
- NCT06590662
- Acronym / sponsor ID
- SOLR-IH / RECHMPL23_0432
- Conditions
- Idiopathic Hypersomnia
- Keywords
- Idiopathic hypersomnia, Solriamfetol, polysomnography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
This Phase II clinical trial is a monocenter, double-blind, randomized, placebo-controlled study aimed at evaluate the efficacy and safety of solriamfetol from 75 to 300 mg per day in IH patients.
Patients will be randomized (1:1) to receive either solriamfetol or placebo, with titration, every morning upon awakening during all treatment periods (Day 0 to Week 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol | Experimental | Drug: SolriamfetolSolriamfetol will be taken once a day upon awakening during 7-weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be taken once a day upon awakening during 7-weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| SolriamfetolPatient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. For the experimental arm, the dose will be progressively increased beginning at 75 mg to 300 mg according to tolerance to treatment. Solriamfetol will be taken once a day upon awakening Schema of dispensation 1. One tablet of solriamfetol 75 mg per day for 1 week (week 1) 2. 150 mg of solriamfetol per day for 2 weeks (weeks 2 and 3) 3. According clinical judgment, Dose either maintained stable at 150 mg or increased to 300 mg per day for 2 weeks (weeks 4 and 5). 4. Prescription at week 5: Dose maintained at 150 or 300 mg or reduced at 150 mg per day according to benefit and safety for 2 weeks. Treatment duration: 7 weeks treatment period. | Drug | Solriamfetol |
| PlaceboPatient with a diagnostic of idiopathic hypersomnia (ICSD-3 criteria) will be randomized to receive solriamfetol or placebo for 7 weeks of treatment period. Placebo will be taken once a day upon awakening Schema of dispensation 1. One tablet of placebo per day for 1 week (week 1) 2. Two tablets of placebo per day for 2 weeks (weeks 2 and 3) 3. According clinical judgment, Either maintained stable with 2 tablets or increased to 4 tablets per day for 2 weeks (weeks 4 and 5). 4. Prescription at week 5: Dose maintained at 2 or 4 tablets or reduced at 2 tablets per day according to benefit and safety for 2 weeks. Treatment duration: 7 weeks placebo period. | Drug | Placebo |
Primary outcome
Idiopathic hypersomnia severity scale (IHSS) score
Time frame: From baseline to week 7
IHSS is a tool used to measure the severity of the symptoms experienced by patients with IH during the previous month. The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10-14 assess daytime functioning alterations due to hypersomnolence. Six items are scored on a 3-point Likert scale and 8 items on a 4-point Likert scale; the Likert scale is a point scale that is used to allow the individual to express how much they agree or disagree with a particular statement. The total IHSS score is the sum of all item scores (range: 0-50), and higher scores indicate more severe symptoms.
14 secondary outcomes
Epworth Sleepiness Scale (ESS) score
Time frame: From baseline to week 7
Maintenance of Wakefulness Test (MWT)
Time frame: From baseline to week 7
Psychomotor vigilance task (PVT)
Time frame: From baseline to week 7
Karolinska Sleepiness Scale (KSS)
Time frame: From baseline to week 7
Sleep inertia questionnaire
Time frame: From baseline to week 7
Clinical Global Impression Scale for Change (CGI-C)
Time frame: From baseline to week 7
Clinical Global Impression Scale for Severity (CGI-S)
Time frame: From baseline to week 7
The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L)
Time frame: From baseline to week 7
Work Productivity and Activity Impairment- General Health (WPAI:GH)
Time frame: From baseline to week 7
Questionnaire on Functional Outcomes of Sleep
Time frame: From baseline to week 7
Logbook for compliance to monitor
Time frame: From baseline to week 7
Percentage of sleep stages
Time frame: From baseline to week 7
Microarousal index
Time frame: From baseline to 7 weeks
Total sleep time
Time frame: From baseline to 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Yves DAUVILLIERS, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solriamfetol in people with 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?
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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yves DAUVILLIERS, MD (+33467335219, y-dauvilliers@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Idiopathic hypersomnia severity scale (IHSS) score (time frame: From baseline to week 7). 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 19 Sep 2024.