Clinical trial NCT06590662: Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
Official title: A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Idiopathic Hypersomnia
Keywords: Idiopathic hypersomnia
Solriamfetol
polysomnography
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Idiopathic hypersomnia severity scale (IHSS) score
timeFrame: From baseline to week 7
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS) score
timeFrame: From baseline to week 7
measure: Maintenance of Wakefulness Test (MWT)
timeFrame: From baseline to week 7
measure: Psychomotor vigilance task (PVT)
timeFrame: From baseline to week 7
measure: Karolinska Sleepiness Scale (KSS)
timeFrame: From baseline to week 7
measure: Sleep inertia questionnaire
timeFrame: From baseline to week 7
measure: Clinical Global Impression Scale for Change (CGI-C)
timeFrame: From baseline to week 7
measure: Clinical Global Impression Scale for Severity (CGI-S)
timeFrame: From baseline to week 7
measure: The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L)
timeFrame: From baseline to week 7
measure: Work Productivity and Activity Impairment- General Health (WPAI:GH)
timeFrame: From baseline to week 7
measure: Questionnaire on Functional Outcomes of Sleep
timeFrame: From baseline to week 7
measure: Logbook for compliance to monitor
timeFrame: From baseline to week 7
measure: Percentage of sleep stages
timeFrame: From baseline to week 7
measure: Microarousal index
timeFrame: From baseline to 7 weeks
measure: Total sleep time
timeFrame: From baseline to 7 weeks
Other outcomes:
measure: 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From baseline to week 8
measure: Actigraphy to detect the wake and sleep cycle
timeFrame: From 1 week before baseline to 1 week before week 7
measure: Pregnancy test (beta HCG blood test)
timeFrame: 90 days before baseline
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Yves DAUVILLIERS, MD
role: PRINCIPAL_INVESTIGATOR
References: