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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effects of low sodium oxybate on individuals with idiopathic hypersomnia, a condition characterized by excessive sleepiness and unusually long sleep durations. Researchers will employ new tools to more accurately determine participants' sleep and wake states. Ideal candidates include those diagnosed with idiopathic hypersomnia, who typically sleep 9 or more hours daily (including naps), and whose doctors have recommended low sodium oxybate. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit a broader range of patients.

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 is the safety track record for low sodium oxybate?

Research has shown that low sodium oxybate is generally well tolerated by adults, with a safety profile similar to sodium oxybate, which treats sleep disorders. People taking low sodium oxybate typically do not experience severe side effects.

Studies have reported common side effects such as nausea, dizziness, and headache, which are similar to those from other sleep medications. Notably, the FDA has already approved low sodium oxybate for treating idiopathic hypersomnia, indicating its safety for this condition.

For those considering joining a trial for this treatment, existing research suggests it is safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Low Sodium Oxybate is unique because it offers a potential new approach for managing idiopathic hypersomnia, a condition characterized by excessive daytime sleepiness. Unlike traditional treatments that may burden patients with high sodium intake, Low Sodium Oxybate reduces sodium content, which could be beneficial for those needing to watch their sodium levels. Researchers are excited about its potential to improve sleep quality and reduce daytime sleepiness without the added sodium load, offering a promising alternative for individuals with idiopathic hypersomnia.

What is the effectiveness track record for low sodium oxybate in treating idiopathic hypersomnia?

Research has shown that low sodium oxybate, which participants in this trial will receive, effectively treats idiopathic hypersomnia, a condition causing excessive daytime sleepiness. Studies have found that people using this treatment felt less sleepy during the day compared to those who took a placebo, a pill with no active medicine. The FDA has approved this treatment for idiopathic hypersomnia, confirming its effectiveness in improving sleep for those with the condition. Patients have reported that switching to low sodium oxybate from other treatments was easy and effective. Overall, low sodium oxybate is a dependable choice for managing symptoms of idiopathic hypersomnia. ^{3 6 7 8 9}

Who Is on the Research Team?

Chad Ruoff, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. investor.jazzpharma.com investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-showcases-phase-4-data-demonstrating-xywavr

Jazz Pharmaceuticals Showcases Phase 4 Data ... It is estimated that far fewer patients are currently receiving pharmacological treatment for their idiopathic hypersomnia.18,19,20,21. About ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9095545/

Calcium, Magnesium, Potassium and Sodium Oxybates ... Lower-sodium oxybate is a valuable treatment option for children and adults with narcolepsy and adults with idiopathic hypersomnia.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12255640/

A Patient-centric Clinical Trial Design to Comprehensively ... This study will comprehensively evaluate multiple daytime and nighttime symptoms in participants with idiopathic hypersomnia and participants with narcolepsy ...

4. xywavhcp.com xywavhcp.com/idiopathic-hypersomnia/efficacy/

XYWAV Efficacy in Idiopathic Hypersomnia Treatment XYWAV has been evaluated across these key measures: · Significant worsening of daytime sleepiness in patients randomized to placebo during the 2-week, double- ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11182

Effectiveness and optimization of low-sodium oxybate in ... Most participants switched from SXB to LXB with minimal modifications of dose/regimen and reported the transition process was easy.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/021196s036,212690s001s006lbl.pdf

XYWAV® (calcium, magnesium, potassium, and sodium ... Idiopathic Hypersomnia. Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.

7. xywav.com xywav.com/

XYWAV for Narcolepsy & Idiopathic Hypersomnia | XYWAV® The only FDA-approved treatment for cataplexy and/or excessive daytime sleepiness in narcolepsy and for idiopathic hypersomnia (IH) in adults.

8. xywavhcp.com xywavhcp.com/idiopathic-hypersomnia/

FDA-Approved Treatment for Idiopathic Hypersomnia - XYWAV XYWAV (calcium, magnesium, potassium, and sodium oxybates) is a nightly medication studied across multiple Idiopathic Hypersomnia symptoms.

9. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(21)00368-9/abstract

Safety and efficacy of lower-sodium oxybate in adults with ... Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study.