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Sodium Oxybate in Idiopathic Hypersomnia (SODHI)

Primary Purpose

Idiopathic Hypersomnia

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Sodium Oxybate Oral Solution 500 MG/ML
Placebos
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypersomnia focused on measuring Idiopathic Hypersomnia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current alcohol intake or treatment with modafinil, amphetamine, methylphenidate, mazindol, pitolisant, neuroleptics, sedative hypnotics, barbiturates, general anesthetics, myorelaxants, other CNS depressants, antidepressants*, anxiolytic drugs, anticonvulsive therapy, topiramate, inhibitors of GHB dehydrogenase (i.e. valproate, ethosuximide, phenytoin), budipine, dopamine antagonist antiemetics (except domperidone), opioids, benzodiazepines, Z-drugs, MAO inhibitors, COMT inhibitors, or sedative antihistamines. 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.

    *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

Sites / Locations

  • University Hospital of Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xyrem

Placebos

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2018
Last Updated
September 26, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03597555
Brief Title
Sodium Oxybate in Idiopathic Hypersomnia
Acronym
SODHI
Official Title
A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Sodium Oxybate in Patients Affected With Idiopathic Hypersomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
April 12, 2023 (Actual)
Study Completion Date
April 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Bicentric, randomized, double-blind controlled study Outpatients aged from 18 to 60 years, suffering from current idiopathic hypersomnia (ICSD-3), recruited via medical consultations in the investigation centers Randomization in Xyrem or placebo arms after the inclusion visit, 1.Screening Period (up to 15 days), 2.Titration Period (up to 45 days), 3.Maintenance Period (minimum 15 days), 4.Safety Follow-Up Period (14 days)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypersomnia
Keywords
Idiopathic Hypersomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xyrem
Arm Type
Experimental
Arm Description
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
Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
Intervention Type
Drug
Intervention Name(s)
Sodium Oxybate Oral Solution 500 MG/ML
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
Primary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS) score at the end-point visit
Description
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.
Time Frame
over 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Current alcohol intake or treatment with modafinil, amphetamine, methylphenidate, mazindol, pitolisant, neuroleptics, sedative hypnotics, barbiturates, general anesthetics, myorelaxants, other CNS depressants, antidepressants*, anxiolytic drugs, anticonvulsive therapy, topiramate, inhibitors of GHB dehydrogenase (i.e. valproate, ethosuximide, phenytoin), budipine, dopamine antagonist antiemetics (except domperidone), opioids, benzodiazepines, Z-drugs, MAO inhibitors, COMT inhibitors, or sedative antihistamines. 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. *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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves DAUVILLIERS
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Montpellier
City
Montpellier
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Sodium Oxybate in Idiopathic Hypersomnia

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