Compares treatment options for Narcolepsy Type 1
Official title A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
ClinicalTrials.gov ID: NCT07598708
What this study is testing
What is cleminorexton?
cleminorexton is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for narcolepsy type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Is willing and able to discontinue all medications used for the treatment of narcolepsy
- Is willing and able to adhere to additional protocol requirements Key
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Denver, North Carolina, United States
- Huntersville, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbia, South Carolina, United States
- Sugar Land, Texas, 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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Miami Lakes, Florida, United States; Denver, North Carolina, United States; Huntersville, North Carolina, United States; Cincinnati, Ohio, United States; Columbia, South Carolina, United States and 1 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.