Status:
NOT_YET_RECRUITING
Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Idiopathic Hypersomnia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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. Pa...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06590662
Start Date
September 15 2024
End Date
June 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
University Hospital of Montpellier
Montpellier, France, 34295