Idiopathic HypersomniaPhase 3NCT03533114
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
A Phase 3 study testing JZP-258 in people with Idiopathic Hypersomnia, run by Jazz Pharmaceuticals at 63 sites in 8 countries.
Trial summary
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- JZP-258
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 63 sitesin 8 countries
- Study dates
- 27 Nov 2018to 18 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 75 years of age, inclusive, at the time of consent.
- Have a primary diagnosis of IH according to the International Classification of Sleep Disorders ICSD-2 or ICSD-3 criteria.
- At the Screening Visit and the Baseline Visit, subjects who are not on Xyrem at study entry must have ESS scores ≥ 11 (as assessed with a look-back period of 1 week).
- If currently treated with Xyrem, must have documented clinical improvement of EDS after the initiation of Xyrem per Investigator's clinical judgment.
- Average nightly total sleep time of ≥ 7 hours, per subject history. Average nightly total sleep time will be confirmed by Investigator's review of sleep diaries collected during the final 2 weeks of the Screening Period.
- If currently treated with stimulants and / or alerting agents or nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose leading up to and throughout the Double-blind Randomized Withdrawal Period.
- Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.
Who cannot join
- Hypersomnia due to another medical, behavioral, or psychiatric disorder condition.
- Evidence of untreated or inadequately treated sleep-disordered breathing.
- Clinically significant parasomnias (eg, sleep walking, rapid eye movement sleep behavior disorder, etc.).
- Current or past (within 1 year) major depressive episode according to DSM-5 criteria. Patients with depression under control are allowed per the judgment of the Investigator or the treating physician and the anti-depressant treatment has to be stable for at least 6 months prior to Screening and remain stable for the duration of the study.
- Current suicidal risk as determined from history by presence of active suicidal ideation as indicated by positive response to item #4 or #5 on C-SSRS, or any history of suicide attempt.
- Occupation requiring nighttime shift work or variable shift work with early work start times or other occupations that could affect the safety of the subject per the judgment of the Investigator.
- Treatment or planned treatment with any CNS sedating agents, including but not limited to benzodiazepines or other sedating anxiolytics, sedating antidepressants, hypnotics, sedatives, neuroleptics, opoids, barbiturates, phenytoin, melatonin, ethosuximide, medications containing valproic acid or its sodium salt, or any other medication in which the subject experiences sedation are prohibited during the study. Treatment must have been discontinued within 2 weeks or 5 half-lives, whichever is longer, prior to enrollment. The Investigator must ensure that discontinuation from these medications is medically supervised. Subjects must abstain from these medications during the study.
- Current or past substance use disorder (including alcohol) according to DSM-5 criteria, or the subject is unwilling to refrain from consuming alcohol, cannabinoids, or prohibited medications during the study.
Trial locations and contacts
63 sites in 8 countries.
63 sites in 8 countries
United States40 sites
NeuroTrials Research
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology
Austin, Texas, 78731
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
Wright Clinical Research, LLC
Birmingham, Alabama, 35243
Alpine Clinical Research Center
Boulder, Colorado, 80301
PAB Clinical Research
Brandon, Florida, 33511
Medical University of South Carolina
Charleston, South Carolina, 29425
American Health Research
Charlotte, North Carolina, 28207
Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Intrepid Research
Cincinnati, Ohio, 45245
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Delta Waves, Inc.
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Neurology Clinic, PC
Cordova, Tennessee, 38018
Geisinger Medical Center
Danville, Pennsylvania, 17822
Ohio Sleep Medicine and Neuroscience Institute
Dublin, Ohio, 43017
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Research Carolina
Huntersville, North Carolina, 28078
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Southern California Institute for Respiratory Diseases, Inc.
Los Angeles, California, 90048
Sleep Practitioners, LLC
Macon, Georgia, 31210
Suncoast Research Group
Miami, Florida, 33135
Bio-Medical Research, LLC
Miami, Florida, 33184
Minnesota Lung Center
Minneapolis, Minnesota, 55435
Coastal Clinical Research
Mobile, Alabama, 36608
Clinical Research of Lake Norman
Mooresville, North Carolina, 28117
Clinical Research of Charleston
Mt. Pleasant, South Carolina, 29464
Lynne Health Science Institute
Oklahoma City, Oklahoma, 73112
Mayo Clinic Building
Phoenix, Arizona, 85054
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Stanford Sleep Medicine Center
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
Baystate Wesson Sleep Clinic
Springfield, Massachusetts, 01199
Clayton Sleep Institute, LLC
St Louis, Missouri, 63146
Clinical Neurophysiology Services, P.C.
Sterling Heights, Michigan, 48314
SleepCare Research Institute d/b/a Clinical Research
Stockbridge, Georgia, 30281
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Montefiore Medical Center/Sleep-Wake Disorders Center
The Bronx, New York, 10467
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario Clinico San Carlos
Madrid, 28040
Hospital Vithas Nuestra Señora de America
Madrid, 28043
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Hospital Universitario Araba
Vitoria-Gasteiz, 01009
France5 sites
CHU de Grenoble - Hôpital Michallon
Grenoble, 38043
Hopital Roger Salengro
Lille, 59037
Hopital Gui de Chauliac
Montpellier, 34295
CHU Nantes - Hopital Nord Laënnec
Nantes, 44093
Hopital Pitie-Salpetriere
Paris, 75651
Belgium3 sites
Anima Research Center
Alken, 3570
Antwerp University Hospital
Edegem, 2650
CHU UCL Namur site de Sainte Elisabeth
Namur, 5000
Czechia3 sites
Nemocnice Ceske Budejovice a.s.
České Budějovice, 370 01
Fakultni nemocnice Hradec Kralove
Hradec Králové, 50333
Vseobecna fakultni nemocnice v Praze
Prague, 128 21
Poland3 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Osrodek Badan Klinicznych CROMED
Poznan, 61-505
lnstytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej
Warsaw, 02-957
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
- Conditions
- Idiopathic Hypersomnia
- Being tested
- JZP-258, Placebo Oral Solution
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JZP-258Drug
Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.
Placebo Oral SolutionDrug
Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
| Study group | Role | What they receive |
|---|---|---|
| JZP-258 | Experimental | JZP-258 at the stable dose and regimen for 2 weeks. Receives: Drug: JZP-258 |
| Placebo | Placebo comparator | Placebo will be administered at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks. Receives: Drug: Placebo Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth Sleepiness Scale (ESS) Score
The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A positive mean change value indicates an increase in score from the end of the stable dose period and worsened daytime sleepiness. A higher ESS score (above 10) reflects a greater average sleep propensity in daily life (ASP) , or daytime sleepiness.
Measured: Change from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period (DBRW) (2 Weeks)
Secondary outcomes (4)
Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc)
The Patient Global Impression - Change (PGIc) scale was completed by the participant. The PGI-C scale rated the participant's condition at a specified time point on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The PGIc scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Worsened condition was defined as a PGIc rating of 5, 6, or 7.
Measured: At the end of the DBRW Period (2 Weeks)
Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS)
The IHSS is a 14-item self-reported questionnaire assessing the severity of IH symptoms of excessive sleepiness, prolonged sleep duration, cognitive impairment and sleep inertia. Total scores can range from 0 to 50, with higher scores indicating a greater severity or frequency of symptoms.
Measured: Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks)
Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc)
The CGIc scale is a 7-point Likert-type scale that rates the Investigator's impression of any change in the severity of the participant's condition at a specified time point. The participant was rated on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The CGIc scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome. Worsened condition was defined as a CGIc rating of 5, 6, or 7.
Measured: At the end of the DBRW Period (2 Weeks)
Change in Total Score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10)
The FOSQ-10 is a short version of the original FOSQ-30 instrument, which is a disease specific quality of life questionnaire to determine functional status in adults. Measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these activities are improved by effective treatment. The questionnaire has a 4-point Likert response format (e.g., 1= extreme difficulty, 2= moderate difficulty, 3=a little difficulty, and 4 =no difficulty). FOSQ-10 total score is calculated by first taking the mean of the items for each subscale with more than 1 item completed and then taking the mean across the non-missing 5 subscales (General Productivity, Activity Level, Vigilance, Social Outcomes, Intimacy and Sexual Relationship) multiplied by 5. The score ranges from a minimum of 5 points to a maximum of 20 points, with higher scores indicating better functional status.
Measured: Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start27 Nov 2018
- Primary completion12 Jun 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Idiopathic HypersomniaStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533114
- Sponsor's protocol ID
- JZP080-301
- Other IDs
- 2018-001311-79, 2018
- Status last verified
- Nov 2021
- First submitted
- 10 May 2018
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin J, Lowe C, Banderas B, Chandler P, Arenson E, Shields AL, Morris S, Srivastava B, Dauvilliers Y. Content Validity and Psychometric Evaluation of the Idiopathic Hypersomnia Severity Scale (IHSS) in Adults with Idiopathic Hypersomnia. Nat Sci Sleep. 2026 Jun 26;18:571289. doi: 10.2147/NSS.S571289. eCollection 2026.
PubMed 42382222Morse AM, Dauvilliers Y, Schneider LD, Fuller DS, Steininger TL, Black J, Thorpy MJ. Effects of low-sodium oxybate on diary-based sleep time in a clinical study in adults with idiopathic hypersomnia. Sleep Med. 2026 Feb;138:108710. doi: 10.1016/j.sleep.2025.108710. Epub 2025 Dec 8.
PubMed 41442817Bogan RK, Fuller DS, Whalen M, Casstevens C, Schneider LD. A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. J Clin Sleep Med. 2025 Jul 1;21(7):1209-1216. doi: 10.5664/jcsm.11662.
PubMed 40135693Morse AM, Dauvilliers Y, Arnulf I, Thorpy MJ, Foldvary-Schaefer N, Chandler P, Chen A, Hickey L, Black J, Bogan RK. Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia. J Clin Sleep Med. 2023 Oct 1;19(10):1811-1822. doi: 10.5664/jcsm.10698.
PubMed 37409509Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Sonka K, Thorpy MJ, Mignot E, Chandler P, Parvataneni R, Black J, Sterkel A, Chen D, Skobieranda F, Bogan RK. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022 Jan;21(1):53-65. doi: 10.1016/S1474-4422(21)00368-9.
PubMed 34942138
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
- ClinicalTrials.gov ID
- NCT03533114
- Acronym / sponsor ID
- JZP080-301
- Conditions
- Idiopathic Hypersomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Posted 24 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JZP-258 | Experimental | Drug: JZP-258JZP-258 at the stable dose and regimen for 2 weeks. |
| Placebo | Placebo comparator | Drug: Placebo Oral SolutionPlacebo will be administered at a volume and regimen equivalent to the JZP-258 dose and regimen for 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 75 years of age, inclusive, at the time of consent.
- Have a primary diagnosis of IH according to the International Classification of Sleep Disorders ICSD-2 or ICSD-3 criteria.
- At the Screening Visit and the Baseline Visit, subjects who are not on Xyrem at study entry must have ESS scores ≥ 11 (as assessed with a look-back period of 1 week).
- If currently treated with Xyrem, must have documented clinical improvement of EDS after the initiation of Xyrem per Investigator's clinical judgment.
- Average nightly total sleep time of ≥ 7 hours, per subject history. Average nightly total sleep time will be confirmed by Investigator's review of sleep diaries collected during the final 2 weeks of the Screening Period.
Key exclusion criteria (8 listed)
- Hypersomnia due to another medical, behavioral, or psychiatric disorder condition.
- Evidence of untreated or inadequately treated sleep-disordered breathing.
- Clinically significant parasomnias (eg, sleep walking, rapid eye movement sleep behavior disorder, etc.).
- Current or past (within 1 year) major depressive episode according to DSM-5 criteria. Patients with depression under control are allowed per the judgment of the Investigator or the treating physician and the anti-depressant treatment has to be stable for at least 6 months prior to Screening and remain stable for the duration of the study.
- Current suicidal risk as determined from history by presence of active suicidal ideation as indicated by positive response to item #4 or #5 on C-SSRS, or any history of suicide attempt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JZP-258Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period. | Drug | JZP-258 |
| Placebo Oral SolutionParticipants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period. | Drug | Placebo |
Primary outcome
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Change from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period (DBRW) (2 Weeks)
The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome. A positive mean change value indicates an increase in score from the end of the stable dose period and worsened daytime sleepiness. A higher ESS score (above 10) reflects a greater average sleep propensity in daily life (ASP) , or daytime sleepiness.
4 secondary outcomes
Percentage of Participants Reported as Worse on the Patient Global Impression of Change (PGIc)
Time frame: At the end of the DBRW Period (2 Weeks)
Change in Total Score on the Idiopathic Hypersomnia Severity Scale (IHSS)
Time frame: Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks)
Percentage of Participants Reported as Worse on the Clinical Global Impression of Change (CGIc)
Time frame: At the end of the DBRW Period (2 Weeks)
Change in Total Score on the Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: Change from the end of the Stable Dose Period to the end of the DBRW Period (2 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42382222Lin J, Lowe C, Banderas B, Chandler P, Arenson E, Shields AL, Morris S, Srivastava B, Dauvilliers Y. Content Validity and Psychometric Evaluation of the Idiopathic Hypersomnia Severity Scale (IHSS) in Adults with Idiopathic Hypersomnia. Nat Sci Sleep. 2026 Jun 26;18:571289. doi: 10.2147/NSS.S571289. eCollection 2026.
- Derived from this study: PubMed 41442817Morse AM, Dauvilliers Y, Schneider LD, Fuller DS, Steininger TL, Black J, Thorpy MJ. Effects of low-sodium oxybate on diary-based sleep time in a clinical study in adults with idiopathic hypersomnia. Sleep Med. 2026 Feb;138:108710. doi: 10.1016/j.sleep.2025.108710. Epub 2025 Dec 8.
- Derived from this study: PubMed 40135693Bogan RK, Fuller DS, Whalen M, Casstevens C, Schneider LD. A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia. J Clin Sleep Med. 2025 Jul 1;21(7):1209-1216. doi: 10.5664/jcsm.11662.
- Derived from this study: PubMed 37409509Morse AM, Dauvilliers Y, Arnulf I, Thorpy MJ, Foldvary-Schaefer N, Chandler P, Chen A, Hickey L, Black J, Bogan RK. Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia. J Clin Sleep Med. 2023 Oct 1;19(10):1811-1822. doi: 10.5664/jcsm.10698.
- Derived from this study: PubMed 34942138Dauvilliers Y, Arnulf I, Foldvary-Schaefer N, Morse AM, Sonka K, Thorpy MJ, Mignot E, Chandler P, Parvataneni R, Black J, Sterkel A, Chen D, Skobieranda F, Bogan RK. Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study. Lancet Neurol. 2022 Jan;21(1):53-65. doi: 10.1016/S1474-4422(21)00368-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
63 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JZP-258 in people with Idiopathic Hypersomnia, run by Jazz Pharmaceuticals at 63 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Spain, France, Belgium, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Epworth Sleepiness Scale (ESS) Score (time frame: Change from the end of the Stable Dose Period to the end of the Double-blind Randomized Withdrawal Period (DBRW) (2 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533114, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.