Low Sodium Oxybate for Idiopathic Hypersomnia

Recruiting at 3 trial locations

Overseen By Gabbi Montefiore

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must be taking: Wake agents, stimulants, antidepressants

Disqualifiers: Suicide history, alcohol abuse, cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.

Will I have to stop taking my current medications?

The trial requires that if you are taking wake-promoting agents, traditional stimulants, or antidepressants, you must be on a stable dose for at least 2 months before joining and continue the same regimen throughout the study.

What data supports the effectiveness of the drug Low Sodium Oxybate for idiopathic hypersomnia?

Research shows that Low Sodium Oxybate (Xywav) effectively improves symptoms of idiopathic hypersomnia, such as excessive daytime sleepiness, in adults. In clinical trials, patients who continued using the drug experienced better symptom control and quality of life compared to those who switched to a placebo. ^{1 2 3 4 5}

Is Low Sodium Oxybate safe for humans?

Low Sodium Oxybate (also known as Xywav) is generally considered safe for humans, with a safety profile similar to Sodium Oxybate. It has been approved for treating sleep disorders like narcolepsy and idiopathic hypersomnia, and its lower sodium content may offer additional health benefits, especially for those with heart-related conditions. ^{1 2 3 4 5}

What makes the drug Low Sodium Oxybate unique for treating idiopathic hypersomnia?

Low Sodium Oxybate is unique because it contains 92% less sodium than the previously used sodium oxybate, reducing the risk of high blood pressure and cardiovascular issues associated with high sodium intake. It is the first drug approved specifically for idiopathic hypersomnia in adults, offering a safer option with similar effectiveness. ^{1 2 3 4 5}

Research Team

Chad Ruoff, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-65 with idiopathic hypersomnia, who often sleep over 10 hours daily including naps. They must be recommended low sodium oxybate by a sleep specialist and agree to use contraception. Exclusions include certain medical conditions like seizure disorders, recent drug abuse, or severe cardiovascular issues.

Inclusion Criteria

A sleep specialist recommended I use a sleep orthosis as part of my treatment.

Your Epworth Sleepiness Scale score is 10 or higher.

You scored 10 or higher on the Epworth Sleepiness Scale.

Exclusion Criteria

I have kidney or liver problems.

I have needed treatment for cancer within the last year.

Subjects who, in the opinion of the investigator(s), may not be suitable for the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are prescribed low sodium oxybate and undergo 24-hour polysomnography, wear an Axivity wristband, and Nextsense EEG earbuds to evaluate total sleep time

3 months

Follow-up

Participants are monitored for changes in total sleep time using patient sleep diary, Axivity device, and Nextsense EEG earbuds

4 weeks

Treatment Details

Interventions

• Low Sodium Oxybate

Trial Overview Researchers are testing the effects of low sodium oxybate on people with idiopathic hypersomnia using novel monitoring tools like polysomnography, EEG earbuds, and an Axivity device to track sleep patterns and wakefulness.

Participant Groups

Group I: Low Soduim Oxybate for Idiopathic Hypersomnia Experimental Treatment 4 Interventions

Subjects prescribed with low sodium oxybate for idopathic hypersomnia will have a 24-hour polysomnography, wear an Axivity wristband and Nextsense EEG earbuds to evaluate total sleep time.

Low Sodium Oxybate is already approved in United States for the following indications:

Approved in United States as Xywav for:

• Idiopathic Hypersomnia
• Cataplexy or Excessive Daytime Sleepiness in Narcolepsy

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Lower-sodium oxybate (Xywav®) is effective in treating cataplexy and excessive daytime sleepiness in adults and children with narcolepsy, as well as idiopathic hypersomnia in adults, based on two phase 3 trials with a randomized-withdrawal design.

Participants who switched to placebo during the trials experienced significant worsening of their symptoms, highlighting the efficacy of lower-sodium oxybate, which also has a tolerability profile similar to that of sodium oxybate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav®) in Sleep Disorders: A Profile of Its Use. Heo, YA.[2022]

Lower-sodium oxybate (LXB) significantly improved symptoms of idiopathic hypersomnia, with mean Epworth Sleepiness Scale scores decreasing from 15.7 to 6.1 and Idiopathic Hypersomnia Severity Scale scores from 31.6 to 15.3 during the treatment period.

The treatment was generally safe, with a decrease in treatment-emergent adverse events (TEAEs) over time; while 22.7% of participants discontinued treatment, the most common side effects like nausea and headache were less frequent as treatment continued.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia. Thorpy, MJ., Arnulf, I., Foldvary-Schaefer, N., et al.[2022]

Low-sodium oxybate (LXB) is an effective treatment for narcolepsy and idiopathic hypersomnia, showing a safety profile similar to sodium oxybate (SXB) while providing additional benefits like reduced sodium intake, which may lower cardiovascular risks.

In clinical trials, LXB not only improved symptoms of excessive daytime sleepiness and cataplexy but also led to weight loss and enhanced quality of life, particularly in younger patients, making it a promising long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Narcolepsy and Idiopathic Hypersomnia with Low-Sodium Oxybate. Schneider, LD., Morse, AM., Strunc, MJ., et al.[2023]

Lower-sodium oxybate (LXB) was developed as a safer alternative to sodium oxybate (SXB), containing 92% less sodium, which helps reduce cardiovascular risks associated with high sodium intake in patients with narcolepsy and idiopathic hypersomnia.

Clinical trials demonstrated that LXB is equally effective as SXB in treating excessive daytime sleepiness and cataplexy, with similar side effects, making it a viable treatment option for patients aged 7 years and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia. Junnarkar, G., Allphin, C., Profant, J., et al.[2022]

Lower-sodium oxybate (LXB) is FDA-approved for treating cataplexy and excessive daytime sleepiness in narcolepsy patients aged 7 and older, and it contains 92% less sodium than sodium oxybate (SXB), reducing the risk of hypertension and cardiovascular issues.

Clinical studies indicate that LXB is effective in managing symptoms of narcolepsy, and its lower sodium content may provide additional safety benefits for patients with existing cardiovascular conditions, although further long-term studies are necessary to confirm these advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium, magnesium, potassium, and sodium oxybates oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy. Abad, VC.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Calcium, Magnesium, Potassium and Sodium Oxybates (Xywav®) in Sleep Disorders: A Profile of Its Use. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Narcolepsy and Idiopathic Hypersomnia with Low-Sodium Oxybate. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Calcium, magnesium, potassium, and sodium oxybates oral solution for cataplexy or excessive daytime sleepiness associated with narcolepsy. [2023]