Sodium Oxybate in Idiopathic Hypersomnia

NCT03597555 | Completed Phase 2

• 1 other identifier: RECHMPL17_0375
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo

Conditions

Idiopathic Hypersomnia

Keywords

Idiopathic Hypersomnia

Outcome Measures

Primary Outcomes (1)

• Epworth Sleepiness Scale (ESS) score at the end-point visit

  Evaluation of difference in sleepiness with ESS between the 2 groups. ESS scores range from 0 to 24; there is a risk of pathological daytime sleepiness if score is \> 10.

  over 8 weeks

Study Arms (2)

Xyrem

EXPERIMENTAL

Xyrem (Sodium Oxybate), oral solution 500mg/mL First night after V1: Dose prescribed at 4.5 g per night (2.25 g x 2) for 2 weeks First night after V2: Dose increased to 6 g per night (3 g x 2) for 2 weeks, according to investigator's opinion, tolerance of drug and CGI-S First night after V3: Dose either maintained stable at 6 g or increased to 9 g per night (4.5 g x 2) with dose increments of 1.5 g per night (0.75 g x 2) every week, based on benefit-risk ratio, for 2 weeks. First night after V4: Dose maintained at 9 g or reduced at 6 g per night according to benefit-risk ratio for 2 weeks. No dose adjustment during the Maintenance period. First night after V5: Taper period. Dose decrease by 2.25 g x 2 every two days until complete withdrawal

Drug: Sodium Oxybate Oral Solution 500 MG/ML

Placebos

PLACEBO COMPARATOR

Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid

Drug: Placebos

Interventions

Sodium Oxybate Oral Solution 500 MG/ML DRUG

First night after V1: Dose prescribed at 4.5 g per night (2.25 g x 2) for 2 weeks First night after V2: Dose increased to 6 g per night (3 g x 2) for 2 weeks, according to investigator's opinion, tolerance of drug and CGI-S First night after V3: Dose either maintained stable at 6 g or increased to 9 g per night (4.5 g x 2) with dose increments of 1.5 g per night (0.75 g x 2) every week, based on benefit-risk ratio, for 2 weeks. First night after V4: Dose maintained at 9 g or reduced at 6 g per night according to benefit-risk ratio for 2 weeks. No dose adjustment during the Maintenance period. First night after V5: Taper period. Dose decrease by 2.25 g x 2 every two days until complete withdrawal

Xyrem

Placebos DRUG

Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid

Placebos

Eligibility Criteria

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

You may qualify if:

• Diagnostic of idiopathic hypersomnia (ICSD-3 criteria)
• Age between 18 and 60 years-old
• BMI between 18 and 35 kg/m2
• MSLT: mean sleep latency (MSL) ≤8 minutes and \< 2 SOREMPs, AND/OR total sleep time \> 11h/24h on 24-hours long-term polysomnography
• Polysomnography recording: sleep efficiency \> 85%, total sleep time ≥6 hours, AHI \<10/hour, micro-arousals index \<15/hour, PLM index associated with micro-arousals \<10/hour.
• Absence of sleep deprivation, assessed by actigraphy or sleep logs
• ESS score ≥14 points
• Written informed consent
• National health insurance cover

You may not qualify if:

• \*30 days for antidepressants
• Previous intake of sodium oxybate
• Succinic semialdehyde dehydrogenase deficiency, porphyria
• Other central nervous system diseases: neurodegenerative diseases, seizure disorders or history of head trauma associated with loss of consciousness
• Lifetime history of suicide attempt or suicidal ideation in the past 6 months, prior history of psychotic episodes, current or recent history of a major depressive disorder (DSM-V), Beck depression inventory (BDI) \> 16 and/or item G\> 0
• 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, severe hypertension or other cardiovascular disease compromising the patient's wellbeing or ability to participate in this study
• Renal or hepatic impairment Compromised respiratory function
• Sleep-related breathing disorders (AHI ≥ 10/h)
• No regular sleep at night: shift work or other continuous non-disease-related life conditions
• Participation in another study of an investigational drug within the 28 days prior to Visit 1 or currently
• Hypersensitivity to any of the components of the study medication
• Pregnancy (βHCG positive) and breast-feeding

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital of Montpellier

Montpellier, France

Location

Related Publications (1)

• Dauvilliers Y, Chenini S, Thobois O, Rassu AL, Denis C, Guiraud L, Jaussent I, Barateau L. Efficacy and Safety of Sodium Oxybate in Adults With Idiopathic Hypersomnia: A Randomized Controlled Trial. Neurology. 2025 Jun 10;104(11):e213690. doi: 10.1212/WNL.0000000000213690. Epub 2025 May 13.

  PMID: 40359459 DERIVED

MeSH Terms

Conditions

Idiopathic Hypersomnia

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Yves DAUVILLIERS

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: October 18, 2018
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)