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A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy.
EU CTIS ID: 2023-504892-25-00
What this study is testing
To evaluate the impact of switching from twice-nightly high-sodium oxybate to XYWAV on 24-hour ambulatory SBP for participants with narcolepsy
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets ICSD-3 or DSM-5 criteria.
- Participants must have been receiving a total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing for a minimum of 6 consecutive weeks prior to screening.
- If currently treated with stimulants and/or alerting agents or other medications known to affect Blood Pressure, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study.
- If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care provider. Also refer to exclusion criterion 12.
- Participant’s average screening SBP must be between 130 and 155 mm Hg (inclusive). Note: BP measurements will be collected using a device provided by the sponsor as described in Section 8.3.2.1. Participants with resistant hypertension are excluded (refer to exclusion criterion 12).
You likely can't join if
- History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the participant or interfere with study assessments or the ability of the participant to complete the study based on the judgment of the investigator.
- Presence of renal impairment with a calculated creatinine clearance < 45 mL/min.
- Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the investigator (clinical chemistry). NOTE: clinical labs may be repeated once during the Screening Period
- Participant has resistant hypertension, defined as one of the following: a. Controlled BP (ie, SBP < 140 mm Hg and DBP < 90 mm Hg) and treated with 4 or more antihypertensive medications. b. Uncontrolled BP (ie, SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg) despite concurrent use of 3 or more antihypertensive medications of different classes that include a diuretic.
- Occupation requiring nighttime or variable shift work.
- Participant was previously eligible for this study but either was terminated early or was discontinued.
See the full eligibility criteria
Who can join
- Participants must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets ICSD-3 or DSM-5 criteria.
- Participants must have been receiving a total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing for a minimum of 6 consecutive weeks prior to screening.
- If currently treated with stimulants and/or alerting agents or other medications known to affect Blood Pressure, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study.
- If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care provider. Also refer to exclusion criterion 12.
- Participant’s average screening SBP must be between 130 and 155 mm Hg (inclusive). Note: BP measurements will be collected using a device provided by the sponsor as described in Section 8.3.2.1. Participants with resistant hypertension are excluded (refer to exclusion criterion 12).
- Participant’s average screening Diastolic blood pressure (DBP) must not be greater than 95 mm Hg. Note: BP measurements will be collected using a device provided by the sponsor as described in Section 8.3.2.1. Participants with resistant hypertension are excluded (refer to exclusion criterion 12).
- Participant is male or female. • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: − Is a woman of nonchildbearing potential OR − Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency, as described in Appendix 4 of the Protocol, during the study intervention period and for at least 7 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. • A WOCBP must have a negative highly sensitive pregnancy test (serum) as required by local regulations during screening (Section 8.3.5 of the Protocol). • Additional requirements for pregnancy testing during and after study intervention are provided in Section 8.3.5 of the Protocol. • The investigator is responsible for review of medical history, contraception history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with an early undetected pregnancy.
What rules you out
- History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the participant or interfere with study assessments or the ability of the participant to complete the study based on the judgment of the investigator.
- Presence of renal impairment with a calculated creatinine clearance < 45 mL/min.
- Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the investigator (clinical chemistry). NOTE: clinical labs may be repeated once during the Screening Period
- Participant has resistant hypertension, defined as one of the following: a. Controlled BP (ie, SBP < 140 mm Hg and DBP < 90 mm Hg) and treated with 4 or more antihypertensive medications. b. Uncontrolled BP (ie, SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg) despite concurrent use of 3 or more antihypertensive medications of different classes that include a diuretic.
- Occupation requiring nighttime or variable shift work.
- Participant was previously eligible for this study but either was terminated early or was discontinued.
- Presence of significant cardiovascular disease including but not limited to: myocardial infarction within the past year, unstable angina pectoris, symptomatic or hospitalized congestive heart failure (ACC/AHA stage C or D), revascularization procedures within the past year, chronic/persistent atrial fibrillation, ventricular cardiac arrhythmias requiring automatic implantable cardioverter defibrillator or anti-arrhythmic therapy, or any significant cardiovascular condition that in the investigator’s opinion may jeopardize participant safety in the study, including screening ECG results.
- Presence of atrial fibrillation detected on screening ECG.
- Current or recent (within the past 2 years) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to DSM-5 criteria. Nicotine use disorder is excluded only if it impacts sleep (ie, a participant who routinely awakens at night to smoke).
- History of phenylketonuria or history of hypersensitivity to phenylalanine-derived products.
- Succinic semi-aldehyde dehydrogenase deficiency by medical history.
- Received an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to the Screening Period, or plans to use an investigational drug (other than the study drug) during the study.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 EU CTIS; the study team decides eligibility.