Excessive Daytime SleepinessPhase 3NCT05223166
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
A Phase 3 study testing Pitolisant in people with Excessive Daytime Sleepiness, run by Citrine Medicine Limited at 1 site in China.
Trial summary
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) not tolerating or refusing the nasal Continuous Positive Airway Pressure (nCPAP)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Excessive Daytime Sleepiness
- What is being tested?
- Pitolisant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2022to 18 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study; fully understand and know the study and sign the informed consent form (ICF); willing to follow and able to complete all study procedures;
- Male or female aged 18 years to 70 years;
- Subjects affected by Obstructive Sleep Apnoea (OSA) with excessive daytime sleepiness;
- Female subjects of childbearing potential must have a negative serum pregnancy test 1 week before the first dose; female subjects or male subjects with a spouse of childbearing potential must agree to take contraceptive measures from the signing of the informed consent form to 1 months after the last dose of study drug;
- Subjects must be willing not to operate a car (if sleepy at wheel) or heavy machinery for the duration of the study or as long as the investigator deems it clinically indicated. In addition, subjects need to be willing to maintain daily behaviors (e.g., circadian rhythm, caffeine intake, nocturnal sleep duration, etc.) during the study that may affect their daytime sleepiness.
Who cannot join
- Participated in any other drug clinical trial or receiving other clinical trial treatment within 30 days before the first dose;
- Subjects who have previously received pitolisant, either from other clinical studies of pitolisant or from the subject use program, or from treatment with commercially available pitolisant (Wakix ®);
- Use of prohibited drugs specified in the protocol within 14 days before enrollment;
- The mean oxygen saturation < 85% or the lowest oxygen saturation < 70% by PSG.
- Acute or chronic diseases affecting efficacy evaluation, such as severe chronic obstructive pulmonary disease (COPD);
- Previous history of drug, alcohol, narcotic or other drug abuse or dependence;
Show all 14Show fewer
- Any serious cardiovascular system abnormalities (e.g., ischemic cardio-cerebral disease), such as recent myocardial infarction, angina, severe hypertension or arrhythmia in the recent 6 months, ECG Fridericia-corrected QT interval higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse;
- Subjects with severe co-morbid medical or biological conditions that may jeopardize participation in the study (especially cardiovascular system problems and unstable diabetes) as judged by the investigator;
- Any positive serology test for HIV, HCV, HBsAg and syphilis;
- Female subjects who are pregnant or breast-feeding;
- Known or suspected hypersensitivity to study drug or to any excipients;
- Cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, which may limit the understanding, execution of the informed consent form, and compliance of the study;
- Presence of severe hepatic insufficiency (Child Pugh C) or severe renal impairment (eGFR<30 ml/min/1.73㎡), or other significant abnormalities in physical examination/clinical laboratory tests, and any clinically significant condition that may interfere with the subject's completion of the study;
- Subjects who are judged by the investigator to be unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) not tolerating or refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS.
- Conditions
- Excessive Daytime Sleepiness
- Being tested
- Pitolisant, Placebo oral tablet
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitolisantDrug
Wakix tablet
Placebo oral tabletDrug
Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant | Experimental | Histamine H3 receptor H3R antagonist/ inverse agonist Receives: Drug: Pitolisant |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of ESS
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start12 Apr 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SleepinessStudies of the same condition, open and under way.
- 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citrine Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223166
- Sponsor's protocol ID
- RSPIT32101
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05223166
- Acronym / sponsor ID
- RSPIT32101
- Conditions
- Excessive Daytime Sleepiness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Citrine Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) not tolerating or refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitolisant | Experimental | Drug: PitolisantHistamine H3 receptor H3R antagonist/ inverse agonist |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (14 listed)
- Participated in any other drug clinical trial or receiving other clinical trial treatment within 30 days before the first dose;
- Subjects who have previously received pitolisant, either from other clinical studies of pitolisant or from the subject use program, or from treatment with commercially available pitolisant (Wakix ®);
- Use of prohibited drugs specified in the protocol within 14 days before enrollment;
- The mean oxygen saturation < 85% or the lowest oxygen saturation < 70% by PSG.
- Acute or chronic diseases affecting efficacy evaluation, such as severe chronic obstructive pulmonary disease (COPD);
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 |
|---|---|---|
| PitolisantWakix tablet | Drug | Pitolisant |
| Placebo oral tabletMatching placebo tablets will be provided for each strength of active pitolisant film-coated tablets. | Drug | Placebo |
Primary outcome
Change from baseline of ESS
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Related trials for Excessive Daytime Sleepiness
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingPhase 3
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
RecruitingPhase 2/3
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Narcolepsy Type 1, Narcolepsy Type 2
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pitolisant in people with Excessive Daytime Sleepiness, run by Citrine Medicine Limited at 1 site in China.
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 5 inclusion and 14 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline of ESS (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2023.