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Sodium Oxybate in Idiopathic Hypersomnia (SODHI)

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ClinicalTrials.gov Identifier: NCT03597555
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE October 18, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Epworth Sleepiness Scale (ESS) score at the end-point visit [ Time Frame: over 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Epworth sleepiness scale score [ Time Frame: over 8 weeks ]
: ESS score at the end-point visit
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium Oxybate in Idiopathic Hypersomnia
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Sodium Oxybate in Patients Affected With Idiopathic Hypersomnia
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Hypersomnia
Intervention  ICMJE
  • Drug: Sodium Oxybate Oral Solution 500 MG/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: Placebos
    Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
Study Arms  ICMJE
  • Experimental: Xyrem

    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

    Intervention: Drug: Sodium Oxybate Oral Solution 500 MG/ML
  • Placebo Comparator: Placebos
    Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
48
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yves DAUVILLIERS, Pr 33 4 67 33 63 61 y-dauvilliers@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03597555
Other Study ID Numbers  ICMJE RECHMPL17_0375
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yves DAUVILLIERS University Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP