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Tests treatment safety and results for Narcolepsy
Official title A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy
ClinicalTrials.gov ID: NCT07493265
What this study is testing
What is E2086?
E2086 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for narcolepsy.
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
- The primary purpose of this study is to evaluate the optimal doses of E2086 compared to placebo in participants with narcolepsy for reduction of excessive daytime sleepiness (EDS) as assessed by Mean Sleep Latency (MSL) (measured from the first 4 maintenance of wakefulness tests [MWTs]).
- Phase 2: a mid-size study of how well it works
- 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 and older
You may be able to join if
- Participants must meet all of the following criteria to be included in this study:
- Male or female, age greater than or equal to (\>=) 18 years (or as regionally appropriate) at the time of informed consent
- NT1 Cohort: Must fulfill 2a and 2b
- Diagnosis of NT1 within the last 10 years of screening, as confirmed by at least one of the following:
- Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, and clinical history, consistent with the 2023 International Classification of...
You likely can't join if
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human...
- Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- total abstinence (if it is their preferred and usual lifestyle)
- an intrauterine device or intrauterine hormone-releasing system (IUS)
- a contraceptive implant
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be included in this study:
- Male or female, age greater than or equal to (\>=) 18 years (or as regionally appropriate) at the time of informed consent
- NT1 Cohort: Must fulfill 2a and 2b
- Diagnosis of NT1 within the last 10 years of screening, as confirmed by at least one of the following:
- Polysomnography (PSG) and Multiple Sleep Latency Test (MSLT) results, and clinical history, consistent with the 2023 International Classification of Sleep Disorders, 3rd edition, text revision (ICSD-3-TR) criteria for...
- Cerebrospinal fluid orexin-A/hypocretin-1 concentration less than or equal to (\<=) 110 picograms per milliliter (pg/mL)
- At least 4 or more episodes of cataplexy/week as averaged over 2 weeks minimum and confirmed by the cataplexy portion of the Diary If PSG or MSLT results are not available within the last 10 years of screening to...
- NT2 Cohort: Diagnosis of NT2 within the last 10 years of screening, as confirmed by PSG and MSLT results, and clinical history, consistent with the 2023 ICSD-3-TR criteria for NT2 If PSG or MSLT results are not...
- ESS score \>=10
- Reports regular bedtime, defined as the time that the participant attempts to sleep, between 22:00 and 01:00 (based on data from the screening Diary)
- Reports regular waketime, defined at the time the participant gets out of bed for the day, between 05:00 and 10:00 (based on data from the screening Diary)
- Reports being in bed between 7 and 9 hours per night (based on data from the sleep portion of the Diary)
- Compliance rate \>=80 percentage (%) for completion of the Diary during screening
- Body mass index (BMI) \>=18 to less than (\<) 35 kilograms per square meter (kg/m\^2) at Screening
What rules you out
- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25...
- Females of childbearing potential who:
- Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
- total abstinence (if it is their preferred and usual lifestyle)
- an intrauterine device or intrauterine hormone-releasing system (IUS)
- a contraceptive implant
- Combined estrogen and progestogen-containing hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation, such as desogestrel (oral...
- have a vasectomized partner with confirmed azoospermia
- Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation. Participants on an oral contraceptive must use an...
- Clinically significant illness that requires medical treatment within 8 weeks of dosing or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing (for example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine...
- Any history of surgery that may affect PK profiles of E2086 (for example, hepatectomy, nephrectomy, digestive organ resection) or who have a congenital abnormality in metabolism at Screening
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, including severe renal impairment (estimated glomerular filtration rate [eGFR] \<30 milliliters per minute (mL/min), and...
- A prolonged QTc interval calculated using Fridericia's formula (QTcF) greater than 450 milliseconds (ms) according to central reading at Screening or Baseline. If the QTcF machine read is greater than 450 ms on the...
- Persistent systolic BP greater than (\>) 130 or \ 85 or \<50 mmHg at Screening (based on BP measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, BP should...
- Persistent HR less than 50 beats/min or more than 100 beats/min at Screening (based on HR measured on at least 3 occasions over 2 weeks), or at Baseline. If outside of these limits at Screening or Baseline, HR should be...
- Any lifetime history of suicidal behavior as indicated by the C-SSRS
- Current unstable psychiatric disorder, current active major depressive episode or an active major depressive episode in the past 6 months
- Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS)
- Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics within 2 years before Screening
- Hypersensitivity to the study drug or any of the excipients
- Intake of herbal preparations containing St. John's Wort within 5x the half-life before dosing
- Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
- Planned surgery that requires general, spinal, or epidural anesthesia that would take place during the study. Planned surgery which requires only local anesthesia and that can be undertaken as a day case without...
- Known to be human immunodeficiency virus (HIV) positive
- Acute Epstein Barr virus (EBV) infection with a positive EBV Viral Capsid Antigen Antibody (VCA) IgM at Baseline
- Known to be hepatitis B virus (HBV)-positive with a detectable HBV (for example, hepatitis B surface antigen [HBsAg] reactive) within 6 months before the 1st dose of study drug, or hepatitis C virus (HCV) positive with...
- Initiation of statin therapy, or a change to a different statin, or an increase in the dose of a statin within the 6 months before the planned start of study drug
- History of formally diagnosed moderate to severe obstructive sleep apnea (OSA)
- Current use of continuous positive airway pressure (CPAP), hypoglossal nerve stimulator, oral device, or other therapy for the treatment of OSA
- Symptomatic restless legs syndrome
- Apnea-hypopnea index \>=15 on Screening PSG
- Use of anticataplectic medications (including but not limited to antidepressants) within 5× the half-life before Screening
- Use of psychostimulant medications, prescription and over-the-counter (OTC), within 5× the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medications include OTC stimulants (for...
- Use of sleep promoting or sedating medications, prescription and OTC, within 5x the half-life before Screening until after the Follow-Up Visit. Examples of prohibited medication include OTC sleep aids, trazodone...
- Inability to discontinue use of strong (such as antifungal itraconazole and antibiotic clarithromycin) and moderate (such as antifungal fluconazole) Cytochrome P450 3A (CYP) 3A inhibitors within 5x the half-life before...
- Inability to discontinue use of CYP3A inducers (such as antibiotic rifampicin and anti-convulsant phenytoin) within 5x the half-life before dosing until after the Follow-Up Visit
- History of drug or alcohol dependency or abuse within 2 years before Screening, or those who have a positive urine drug test or breath (or urine) alcohol test at Screening or Baseline
- Does not agree to abstain from use of recreational drugs during the study
- Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5x the half-life, whichever is longer, preceding informed consent
- Receipt of blood products within 4 weeks of dosing, donation of blood within 8 weeks of dosing, or donation of plasma within 1 week of dosing
- Past participation in a study of an orexin agonist if discontinuation of orexin agonist use was related to an adverse drug reaction or inefficacy
The study team makes the final eligibility decision.
Where it's taking place
- Santa Ana, California, United States
- Brandon, Florida, United States
- Medley, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Stockbridge, Georgia, United States
- Baltimore, Maryland, United States
- Lansing, Michigan, United States
- Novi, Michigan, United States
- Southfield, Michigan, United States
- Denver, North Carolina, United States
- Columbia, South Carolina, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Alken, Belgium
- Ghent, Belgium
- Calgary, Alberta, Canada
- Markham, Ontario, Canada
- Ottawa, Ontario, Canada
+ 31 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Ana, California, United States; Brandon, Florida, United States; Medley, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Macon, Georgia, United States and 45 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.