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

NCT06590662 | Not Yet Recruiting Phase 2

• 1 other identifier: RECHMPL23_0432
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Idiopathic Hypersomnia

Keywords

Idiopathic hypersomnia; Solriamfetol; polysomnography

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to week 7

Secondary Outcomes (14)

• Epworth Sleepiness Scale (ESS) score

  From baseline to week 7

• Maintenance of Wakefulness Test (MWT)

  From baseline to week 7

• Psychomotor vigilance task (PVT)

  From baseline to week 7

• Karolinska Sleepiness Scale (KSS)

  From baseline to week 7

• Sleep inertia questionnaire

  From baseline to week 7

Other Outcomes (3)

• 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

  From baseline to week 8

• Actigraphy to detect the wake and sleep cycle

  From 1 week before baseline to 1 week before week 7

• Pregnancy test (beta HCG blood test)

  90 days before baseline

Study Arms (2)

Solriamfetol

EXPERIMENTAL

Solriamfetol will be taken once a day upon awakening during 7-weeks

Drug: Solriamfetol

Placebo

PLACEBO COMPARATOR

Placebo will be taken once a day upon awakening during 7-weeks

Drug: Placebo

Interventions

Solriamfetol DRUG

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. 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.

Solriamfetol

Placebo DRUG

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 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Idiopathic Hypersomnia

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yves DAUVILLIERS, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves DAUVILLIERS, MD

CONTACT

+33467335219; y-dauvilliers@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)