Help Contribute to Critical IH and Narcolepsy Treatment Research
Help Contribute to Critical IH and Narcolepsy Treatment Research
Living With Sleep Disorders
For people living with IH or narcolepsy, symptoms such as excessive daytime sleepiness (EDS), cataplexy and sleep inertia can impact how they perform at their job, build relationships and tackle everyday tasks. Activities such as quality time with family and hobbies may be neglected. Even while on treatment, some may still need to continually manage their symptoms.
Lack of quality sleep has been linked to the development of several chronic diseases and conditions, including Type 2 diabetes, cardiovascular disease, obesity and depression.1 As narcolepsy, and potentially IH, carry a higher risk of developing cardiovascular disease, daily high sodium intake can be a concern. Reducing sodium intake can help reduce the risk of high blood pressure and heart disease.
The DUET Study will evaluate the daytime and nighttime effects of XYWAV, a low-sodium oral solution for IH and narcolepsy.
About the DUET Study
The DUET Study is an open-label, multinational phase 3/4 study targeting adult IH and narcolepsy (Type 1 and Type 2) patients. Every participant will receive XYWAV, a low-sodium oral solution for IH and narcolepsy, and the study doctor will determine each participant’s optimal dosage, which could be 1 or 2 doses nightly for up to 5 months for a cohort.
Participation in a study cohort is comprised of a:
- 2 to 6–week screening period
- 8-day baseline period
- 5 to 12–week treatment period
- 2-week follow-up period
The DUET Study has an estimated enrollment target of 186 IH and narcolepsy (Type 1 or Type 2) participants.
What Should Your Patients Expect?
Participants will be expected to:
- Attend both clinic and virtual visits
- At the clinic visits, participants will complete several questionnaires related to their condition and how they are feeling
- Some of the clinic visits will be overnight sleep studies
- Take XYWAV orally every night during the treatment period
- Complete daily electronic diaries during the baseline period and treatment period
If your patients are on an anticataplectic, alerting agent or nicotine replacement therapy, they must remain on a stable dose with no current plans to adjust the dosage during the study period to participate.
If you have questions about the study, please visit ClinicalTrials.gov to reach out to a DUET Study site. If you have a patient who you feel may be interested in participation, please refer them to the study website.
Can Your Patients Join?
Your patients are qualified for the DUET Study if they:
- Are 18 to 75 years of age
- Have a primary diagnosis of IH or narcolepsy (Type 1 or Type 2)
- Have symptoms of EDS (Epworth Sleepiness Scale [ESS] score >10) if not currently taking oxybate medication
- Have a stable dose and no current plans to adjust the dosage if currently treated with anticataplectics, alerting agents or nicotine replacement therapy
If you have questions about the study, please visit ClinicalTrials.gov to reach out to a DUET Study site. If you have a patient who you feel may be interested in participation, please refer them to the study website.
Prior to enrolling in this study, your patients cannot have:
- A history or presence of bipolar disorder, schizophrenia or other similar disorders
- A current seizure disorder
- A job where the working hours can change throughout the day and night
- Plans for travel across more than 3 time zones during the study
Are your patients eligible?
92%
less sodium
About XYWAV
The DUET Study will investigate multiple daytime and nighttime symptoms, as well as functional impacts of XYWAV. XYWAV was developed as a low-sodium formulation of XYREM® (sodium oxybate), and it contains 92% less sodium than XYREM.2 XYWAV can help reduce sodium intake, a modifiable risk factor for cardiovascular disease. XYWAV is approved for the treatment of IH in adults and for the treatment of cataplexy or EDS in people 7 years of age and older with narcolepsy.
Share DUET With Your Colleagues
The DUET Study will help advance research that may better inform how we treat sleep disorders such as IH and narcolepsy. Without referrals from doctors like you, this important research would not be possible.
References:
- Sleep and chronic disease. Centers for Disease Control and Prevention. Updated September 13, 2022. Accessed June 1, 2023. https://www.cdc.gov/sleep/about_sleep/chronic_disease.html
- XYREM and XYWAV. Jazz Pharmaceuticals. Accessed May 25, 2023. https://www.xywav.com/narcolepsy/lower-sodium-oxybate-treatment-option/