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New treatment option for Idiopathic Hypersomnia
Official title Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
ClinicalTrials.gov ID: NCT05837091
What this study is testing
What is Low Sodium Oxybate?
Low Sodium Oxybate is an investigational medicine, being studied as a potential treatment for idiopathic hypersomnia.
Also referred to as Xywav, Calcium, Magnesium, Potassium, and Sodium Oxybates.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)
- people aged 18 - 65 years
- BMI between 18 and 35 kg/m2
- Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries
- Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)
You likely can't join if
- 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 six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score \>...
- Change to psychiatric medication(s)/stimulant(s) within last 3 months
- History of chronic alcohol or drug abuse within the prior 12 months
- Malignant neoplastic disease requiring therapy within the prior 12 months
See the full eligibility criteria
- Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT)
- people aged 18 - 65 years
- BMI between 18 and 35 kg/m2
- Self-reported sleep duration ≥ 9 hours most days including daytime naps/sleep based upon at least 10/14 days of completed sleep diary entries
- Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only)
- Recommended LSO by a clinical sleep specialist as part of routine medical care. The clinical sleep specialist will be responsible for titrating LSO according to standard of care.
- Subject must be willing to postpone LSO therapy until all baseline assessments completed
- If treated with wake promoting agents, traditional stimulants and/or antidepressant(s), a stable dose and regimen will be required for at least 2 months before study entry and throughout the main study
- Have used a medically acceptable method of contraception for at least 2 full menstrual cycles before participating in this study and consent to use a medically acceptable method of contraception from the first dose of...
- 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 six months, including answer to question #9 on PHQ-9 ≥1; PHQ-9 total score \> 10; prior history of psychotic episodes; active major depressive disorder
- Change to psychiatric medication(s)/stimulant(s) within last 3 months
- History of chronic alcohol or drug abuse within the prior 12 months
- Malignant neoplastic disease requiring therapy within the prior 12 months
- Heart failure, severe hypertension or other cardiovascular disease compromising the patient's well-being or ability to participate in this study
- Renal or hepatic impairment
- Compromised respiratory function (e.g., history of COPD, pulmonary hypertension, and/or poorly controlled asthma)
- Diagnosis of sleep-related breathing disorders (AHI ≥ 15 events/h using 4 % AHI) or high suspicion for sleep disordered breathing
- Any sleep apnea treatment (e.g., Positive Airway Pressure (PAP) therapy, oral appliance therapy, etc.)
- 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 Screening visit or currently
- Pregnant and/or breast-feeding
- Ear jewelry and/or piercings that subject not willing to/unable to remove
- Use of device/implant that may interfere with the study devices/procedures (e.g., vagal nerve stimulator)
- Smoke and/or use of smokeless tobacco products
- people who, in the opinion of the investigator(s), may not be suitable for the study
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Redwood City, California, United States
- Jacksonville, Florida, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Redwood City, California, United States; Jacksonville, Florida, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.