Phase 2 Narcolepsy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older at the time of giving consent to participate
• People in the Narcolepsy Type 1 (NT1) group must have been diagnosed with NT1 within the last 10 years, confirmed by specific sleep study results and medical history, or by a spinal fluid test showing very low levels of a brain chemical called orexin/hypocretin
• People in the NT1 group must also experience 4 or more cataplexy episodes (sudden muscle weakness) per week, on average over at least 2 weeks, as recorded in a diary
• People in the Narcolepsy Type 2 (NT2) group must have been diagnosed with NT2 within the last 10 years, confirmed by specific sleep study results and medical history
• People who score 10 or higher on a standard daytime sleepiness questionnaire (the Epworth Sleepiness Scale)
• People who regularly try to go to sleep between 10:00 pm and 1:00 am, as recorded in a diary
• People who regularly get out of bed for the day between 5:00 am and 10:00 am, as recorded in a diary
• People who spend between 7 and 9 hours in bed each night, as recorded in a diary
• People who completed their sleep diary at least 80% of the time during the screening period
• People with a body mass index (a measure of body weight relative to height) between 18 and 35

Who may not be able to join:

• People who are pregnant or breastfeeding at the time of screening or before the first dose
• Women who could become pregnant and have not been using a highly effective form of contraception (such as an IUD, implant, hormonal contraception, or having a partner with a confirmed vasectomy) for at least 28 days before joining, and who do not agree to continue using one throughout the study and for 28 days after the study ends (confirm with trial site for full details on accepted methods)
• People who have had a significant illness requiring treatment within the past 8 weeks, or a significant infection requiring treatment within the past 4 weeks
• People with certain active medical conditions affecting organs such as the liver, kidneys, heart, lungs, or nervous system within 4 weeks before the first dose
• People who have had certain surgeries that could affect how the study drug is processed by the body (such as removal of part of the liver, kidney, or digestive organs), or who have an inherited condition affecting metabolism
• People with significantly abnormal results from medical tests, including severely reduced kidney function, found during screening
• People with an abnormal heart electrical reading (a measurement called QTcF greater than 450 milliseconds) at screening or baseline
• People with persistently high or low blood pressure (above 130 or below 100 for the top number, or above 85 or below 50 for the bottom number) at screening or baseline
• People with a persistently very slow or very fast heart rate (below 50 or above 100 beats per minute) at screening or baseline
• People with any lifetime history of suicidal behaviour, as measured by a standard assessment tool
• People with a current unstable mental health condition, or a major depressive episode currently or within the past 6 months
• People who have had thoughts of suicide with intent, with or without a plan, at screening or within the 6 months before screening
• People with a psychotic disorder or unstable recurring mood disorder, including those who have taken antipsychotic medication within the past 2 years
• People with a known allergy or sensitivity to the study drug or its ingredients
• People who have taken herbal products containing St. John's Wort recently before dosing (confirm exact timeframe with trial site)
• People with any other medical condition that, in the opinion of the study doctor, could make participation unsafe
• People who have planned surgery requiring general, spinal, or epidural anaesthesia during the study period
• People who are HIV positive
• People with an active Epstein-Barr virus (a virus that causes glandular fever) infection at baseline
• People with active Hepatitis B or Hepatitis C virus infection (confirm details with trial site, as some people with previously resolved Hepatitis C may be eligible)
• People who have started taking a cholesterol-lowering statin medication, switched to a different statin, or increased their statin dose within the past 6 months
• People with a previously formally diagnosed moderate to severe obstructive sleep apnea
• People currently using a CPAP machine, nerve stimulator, oral device, or other treatment for obstructive sleep apnea
• People with symptomatic restless legs syndrome
• People whose sleep study during screening shows a breathing disturbance score of 15 or higher
• People who have recently used medications to treat cataplexy, including certain antidepressants (confirm exact timeframe with trial site)
• People who have recently used stimulant medications — including prescription or over-the-counter types such as modafinil, amphetamines, or sodium oxybate — before screening through to the follow-up visit (confirm exact timeframe with trial site)
• People who have recently used sleep-promoting or sedating medications — including over-the-counter sleep aids, benzodiazepines, melatonin, or opioids — before screening through to the follow-up visit (confirm exact timeframe with trial site)
• People who are unable to stop taking certain medications that strongly or moderately affect how the body processes drugs (such as some antifungal or antibiotic medications) within the required period before and during the study
• People who are unable to stop taking certain medications that reduce how the body processes drugs (such as rifampicin or phenytoin) within the required period before and during the study
• People with a history of drug or alcohol dependency or misuse within the past 2 years, or who test positive for drugs or alcohol at screening or baseline
• People who do not agree to avoid recreational drugs during the study
• People currently in another clinical trial, or who have used an investigational drug or device within 28 days or a longer period before giving consent
• People who have received blood products within 4 weeks of dosing, donated blood within 8 weeks, or donated plasma within 1 week of dosing
• People who have previously participated in a trial of an orexin-activating drug and stopped due to a bad reaction to that drug or because it did not work

Important: Always verify eligibility with the trial site directly before applying.