Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

Официальное название

A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia.

Обзор

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).

Вмешательства

• Препарат Solriamfetol
  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 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. Acc
• Препарат Placebo
  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 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 w

Первичные конечные точки

• Idiopathic hypersomnia severity scale (IHSS) score [Срок оценки: From baseline to week 7]

Вторичные конечные точки (12)

• Epworth Sleepiness Scale (ESS) score [Срок оценки: From baseline to week 7]
• Maintenance of Wakefulness Test (MWT) [Срок оценки: From baseline to week 7]
• Psychomotor vigilance task (PVT) [Срок оценки: From baseline to week 7]
• Karolinska Sleepiness Scale (KSS) [Срок оценки: From baseline to week 7]
• Sleep inertia questionnaire [Срок оценки: From baseline to week 7]
• Clinical Global Impression Scale for Change (CGI-C) [Срок оценки: From baseline to week 7]
• Clinical Global Impression Scale for Severity (CGI-S) [Срок оценки: From baseline to week 7]
• The EuroQol 5-Dimensional Descriptive System (EQ-5D-3L) [Срок оценки: From baseline to week 7]
• Work Productivity and Activity Impairment- General Health (WPAI:GH) [Срок оценки: From baseline to week 7]
• Questionnaire on Functional Outcomes of Sleep [Срок оценки: From baseline to week 7]
• Logbook for compliance to monitor [Срок оценки: From baseline to week 7]
• Percentage of sleep stages [Срок оценки: From baseline to week 7]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• University Hospital of Montpellier — Montpellier

Идентификаторы

NCT: NCT06590662 · RECHMPL23_0432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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