A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cleminorexton, Placebo.
- Who it may be relevant to
- Registry conditions: Narcolepsy Type 1, Narcolepsy Type 2. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence
Overview
Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \[EDS\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities. While all conditions result in feeling sleepy, there are some differences in other common symptoms: * NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night. * NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy. Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.
Detailed description
The SAPPHIRE Clinical Trial
The Sponsor may in the future, through a protocol amendment, expand the protocol to include participants with idiopathic hypersomnia (IH) in Cohort C.
Interventions
- Drug cleminorexton
Oral cleminorexton capsule - Drug Placebo
matching placebo capsule
Primary outcome measures
- Change from baseline in mean sleep latency (average of the first 4 trials) on the Maintenance of Wakefulness Test (MWT) [Time frame: Baseline to week 12]
Secondary outcome measures (12)
- Change from baseline in Epworth Sleepiness Scale (ESS) total score [Time frame: Baseline to Week 12]
- Weekly Cataplexy Rate (WCR) [Time frame: Week 12]
- Change from baseline in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) [Time frame: Baseline to Week 12]
- Change from baseline in Narcolepsy Severity Scale-2 for Clinical Trials (NSS2-CT) total score [Time frame: Baseline to Week 12]
- Incidence, Severity, and casual relationship of participants with Treatment Emergent Adverse Events (TEAEs) [Time frame: Baseline to Week 12]
- Number of participants with abnormal changes from baseline in clinical laboratory tests [Time frame: Baseline to Week 12]
- Number of participants with abnormal changes from baseline in vital signs [Time frame: Baseline to Week 12]
- Number of participants with abnormal changes from baseline in 12-lead electrocardiograms (ECGs) [Time frame: Baseline to Week 12]
- Number of participants with at least 1 endorsement of Item 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline to Week 12]
- Cmax: Maximum observed plasma concentration [Time frame: Baseline to Week 12]
- Tmax: Time of Maximum Concentration for cleminorexton [Time frame: Baseline to Week 12]
- AUC: Area under the plasma concentration-time curve [Time frame: Baseline to Week 12]
Eligibility criteria
Inclusion criteria
- 18-70 years of age
- Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg/m\^2 (inclusive)
- Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria
- Is willing and able to discontinue all medications used for the treatment of narcolepsy
- Is willing and able to adhere to additional protocol requirements
Exclusion criteria
- Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)
- Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- Colorado Springs, Colorado — Colorado Springs
- Miami, Florida — Miami
- Miami Lakes, Florida — Miami Lakes
- Flowood Mississippi — Flowood
- Denver, North Carolina — Denver
- Huntersville, North Carolina — Huntersville
- Cincinnati, Ohio — Cincinnati
- Dublin, Ohio — Dublin
- … and 2 more centers
Identifiers
NCT: NCT07598708 · ORX750-004