Narcolepsy
Conditions
Keywords
Narcolepsy Type 1, Narcolepsy Type 2, JZP258, Oxybate, Xywav
Brief summary
The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to Xywav, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.
Interventions
DRUGJZP258
0.5 g/ml calcium, magnesium, potassium, and sodium oxybates oral solution
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 International Classification of Sleep Disorders (ICSD)-3 or Diagnostic and Statistical Manual of Mental Disorders (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 BP, 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 * Participant is male or female. A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is a woman of nonchildbearing potential or is a woman of childbearing potential and using a contraceptive method that is highly effective. Key
Exclusion criteria
* 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 significant cardiovascular disease or 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 electrocardiogram (ECG). * Presence of resistant hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline to EOT Visit on the Daytime Average SBP in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
| Change From Baseline to EOT Visit on the Seated Resting Average SBP in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
| Change From Baseline to EOT Visit on the Nighttime Average SBP in mmHg | Baseline (Screening) and End of Treatment (EOT) Visit, up to 6 weeks |
Countries
Belgium, France, Italy, Spain, United States
Participant flow
Recruitment details
A total of 155 participants is in the enrolled analysis set. The enrolled analysis set includes all participants who provided informed consent for this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 155 | 0 / 67 |
| other Total, other adverse events | 0 / 0 | 11 / 67 |
| serious Total, serious adverse events | 0 / 155 | 1 / 67 |
Outcome results
None listed