E2086 for Narcolepsy
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Eisai Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in adult participants with narcolepsy type 1 (NT1).
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop taking certain medications. The trial prohibits the use of anti-cataplectic medications, psychostimulant medications, and sleep-promoting medications within specific time frames before screening. This includes medications like pseudoephedrine, methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pemoline, trazodone, hypnotics, benzodiazepines, barbiturates, cannabinoids, and opioids.
What data supports the idea that E2086 for Narcolepsy is an effective drug?
The available research shows that E2086, also known as sodium oxybate, is effective in treating narcolepsy by improving nighttime sleep and reducing excessive daytime sleepiness. A study compared sodium oxybate with other treatments like modafinil and found it effective in managing disrupted nighttime sleep. Additionally, a network meta-analysis highlighted that sodium oxybate is one of the approved wake-promoting agents for narcolepsy, indicating its effectiveness in reducing daytime sleepiness. These findings suggest that E2086 is a beneficial option for people with narcolepsy.
12345What safety data is available for the treatment E2086 for Narcolepsy?
The provided research does not contain specific safety data for the treatment E2086 for Narcolepsy. The articles discuss general adverse events in phase-I studies, drug safety surveillance, and risk evaluation strategies, but none specifically mention E2086 or its safety profile.
678910Is the drug E2086 a promising treatment for narcolepsy?
The drug E2086 is considered promising for narcolepsy because it is part of emerging therapies that aim to improve symptoms like excessive daytime sleepiness and cataplexy. New treatments are being developed to address the underlying causes of narcolepsy, such as the loss of certain brain cells, and E2086 is among these innovative approaches.
1112131415Eligibility Criteria
Adults over 18 with narcolepsy type 1 can join this trial. They must have specific sleep test results showing severe daytime sleepiness and a history of cataplexy. Participants should have regular sleeping hours, a BMI between 18-40, and experience daily periods of extreme need to sleep or napping for at least three months.Inclusion Criteria
I am 18 years old or older.
I have a sleep disorder with quick sleep onset and rapid REM phases.
My sleep study showed I entered REM sleep unusually fast.
+7 more
Participant Groups
The study tests E2086's effectiveness against placebo in reducing excessive daytime sleepiness in adults with narcolepsy type 1. The Maintenance of Wakefulness Test measures the success of the treatment.
10Treatment groups
Experimental Treatment
Group I: Sequence 9, BACED: E2086 Dose 1 + Placebo + E2086 Dose 2 + Active Comparator + E2086 Dose 3Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group II: Sequence 8, AEBDC: Placebo + Active Comparator + E2086 Dose 1 + E2086 Dose 3 + E2086 Dose 2Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group III: Sequence 7, EDACB: Active Comparator + E2086 Dose 3 + Placebo + E2086 Dose 2 + E2086 Dose 1Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group IV: Sequence 6, DCEBA: E2086 Dose 3 + E2086 Dose 2 + Active Comparator + E2086 Dose 1 + PlaceboExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group V: Sequence 5, EADBC: Active Comparator + Placebo + E2086 Dose 3 + E2086 Dose 1 + E2086 Dose 2Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group VI: Sequence 4, DECAB: E2086 Dose 3 + Active Comparator + E2086 Dose 2 + Placebo + E2086 Dose 1Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group VII: Sequence 3, CDBEA: E2086 Dose 2 + E2086 Dose 3 + E2086 Dose 1 + Active Comparator + PlaceboExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group VIII: Sequence 2, BCADE: E2086 Dose 1 + E2086 Dose 2 + Placebo + E2086 Dose 3 + Active ComparatorExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group IX: Sequence 10, CBDAE: E2086 Dose 2 + E2086 Dose 1 + E2086 Dose 3 + Placebo + Active ComparatorExperimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Group X: Sequence 1, ABECD: Placebo + E2086 Dose 1 + Active Comparator + E2086 Dose 2 + E2086 Dose 3Experimental Treatment4 Interventions
Participants will receive 3 doses of E2086, an active comparator, E2086 matching placebo and active comparator matching placebo, all as oral tablets.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
PharmaDev Clinical ResearchMiami, FL
Sleep Practioners, LLCMacon, GA
Clinical Research InstituteStockbridge, GA
Sound Asleep Research, Inc.Lansing, MI
More Trial Locations
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Who Is Running the Clinical Trial?
Eisai Inc.Lead Sponsor
References
Quality measures for the care of patients with narcolepsy. [2018]The American Academy of Sleep Medicine (AASM) commissioned a Workgroup to develop quality measures for the care of patients with narcolepsy. Following a comprehensive literature search, 306 publications were found addressing quality care or measures. Strength of association was graded between proposed process measures and desired outcomes. Following the AASM process for quality measure development, we identified three outcomes (including one outcome measure) and seven process measures. The first desired outcome was to reduce excessive daytime sleepiness by employing two process measures: quantifying sleepiness and initiating treatment. The second outcome was to improve the accuracy of diagnosis by employing the two process measures: completing both a comprehensive sleep history and an objective sleep assessment. The third outcome was to reduce adverse events through three steps: ensuring treatment follow-up, documenting medical comorbidities, and documenting safety measures counseling. All narcolepsy measures described in this report were developed by the Narcolepsy Quality Measures Work-group and approved by the AASM Quality Measures Task Force and the AASM Board of Directors. The AASM recommends the use of these measures as part of quality improvement programs that will enhance the ability to improve care for patients with narcolepsy.
Effect of sodium oxybate, modafinil, and their combination on disrupted nighttime sleep in narcolepsy. [2018]To assess the effects of three narcolepsy treatment modalities on sleep stage shifts associated with disrupted nighttime sleep (DNS) using data from a clinical trial.
Effects of Pharmacotherapy Treatment on Patient-Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort. [2023]We aimed to evaluate the association between patient-reported outcomes (PROs) and treatment regimen/standardized dose (STD), a measure of drug burden, in patients with narcolepsy type 1 (NT1)/type 2 (NT2) and idiopathic hypersomnia (IH).
Comparative Efficacy and Safety of Multiple Wake-Promoting Agents for the Treatment of Excessive Daytime Sleepiness in Narcolepsy: A Network Meta-Analysis. [2023]Narcolepsy is a rare debilitating disorder for which multiple novel pharmacological options have been approved as treatment for the past few years. The current study systematically updates the comparative efficacy and detailed safety analysis of approved wake-promoting agents in narcolepsy.
The Impact of Symptom Severity on Health-Related Quality of Life in People with Narcolepsy Type 1. [2023]To assess the impact of symptom severity on health-related quality of life (HRQoL) in people with narcolepsy type 1 (NT1).
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]This report describes all clinical, laboratory and electrocardiographical adverse events detected in healthy volunteers in a phase-I centre over a 10-year period: 54 phase-I studies are involved, including 1015 healthy young volunteers (993 males) who received 1538 treatments (23 different active drugs or placebo) corresponding to 12143 days of follow-up. This updates a similar report published previously in the European Journal of Clinical Pharmacology.
An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance. [2020]The most commonly reported adverse event, based on frequency of Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), in the US FDA Adverse Event Reporting System (FAERS) database is "drug ineffective" (DI). This study aimed to describe the DI reports and provide data to support recommendations on how to best evaluate these reports.
Fatigue during treatment with antiepileptic drugs: A levetiracetam-specific adverse event? [2018]To examine the prevalence and clinical correlates of fatigue as an adverse event (AE) of antiepileptic drug (AED) treatment in patients with epilepsy.
Risk evaluation and mitigation strategies (REMS): educating the prescriber. [2021]The US FDA Amendments Act of 2007 was signed into law on 27 September 2007. A provision of this law granted the FDA new powers to enhance drug safety by requiring the pharmaceutical industry to develop Risk Evaluation and Mitigation Strategies (REMS). REMS are deemed necessary when a question exists as to whether the benefits of a drug outweigh its risks. REMS constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients. This applies to existing drugs on the market, new drug applications (NDAs), abbreviated NDAs (generics) and biologics licence applications. REMS represent an 'upgrade' from previously required risk minimization action plans, based on the strengthening of FDA powers of authority and enforceability to incur monetary penalties against individuals representing the pharmaceutical industry who fail to comply. For illustrative purposes, we chose the drug romiplostim (Nplate®) to present an REMS, as all components were utilized to help assuage risks associated with the drug. Romiplostim is an FDA-approved drug used to treat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura that has a significant adverse safety profile based on the risk of changes in bone marrow reticulin formation and bone marrow fibroses, and other associated risks. This review of current REMS policy is intended to provide the prescriber with a better understanding of current modalities in FDA-mandated drug safety programmes, which will impact day-to-day healthcare provider practices.
A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations. [2019]To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report.
Metabolic-Syndrome-Related Comorbidities in Narcolepsy Spectrum Disorders: A Preliminary Cross-Sectional Study in Japan. [2022]Narcolepsy types 1 (NT1) and 2 (NT2) and idiopathic hypersomnia (IH) are thought to be a disease continuum known as narcolepsy spectrum disorders (NSDs). This study aimed to assess the prevalence of and factors associated with metabolic-syndrome-related disorders (MRDs) among patients with NSD. Japanese patients with NSD (NT1, n = 94; NT2, n = 83; and IH, n = 57) aged ≥35 years were enrolled in this cross-sectional study. MRD was defined as having at least one of the following conditions: hypertension, diabetes, or dyslipidemia. Demographic variables and MRD incidence were compared among patients in the respective NSD categories. Multivariate logistic regression analysis was used to investigate the factors associated with MRDs. Patients with NT1 had a higher body mass index (BMI) and incidence of MRD than that had by those with NT2 or IH. Age, BMI, and the presence of OSA were significantly associated with the incidence of MRD in NSDs. Age and BMI in NT1, BMI and human leukocyte antigen (HLA)-DQB1*06:02 positivity in NT2, and only age in IH were factors associated with the incidence of MRD. Obesity should be carefully monitored in narcolepsy; however, NT2 with HLA-DQB1*06:02 positive should be followed up for the development of MRD even without obesity.
The neurobiology of hypocretins (orexins), narcolepsy and related therapeutic interventions. [2015]Narcolepsy is characterized by excessive daytime sleepiness, cataplexy and other manifestations of dissociated rapid eye movement sleep. Narcolepsy is typically treated with amphetamine-like stimulants (sleepiness) and antidepressants (cataplexy). Newer compounds, such as modafinil (non-amphetamine wake-promoting compound for excessive daytime sleepiness) and sodium oxybate (short-acting sedative for fragmented nighttime sleep, cataplexy, excessive daytime sleepiness), are increasingly used. Recent discoveries indicate that the major pathophysiology of human narcolepsy is the loss of lateral hypothalamic neurons that produce the neuropeptide hypocretin (orexin). Approximately 90% of people diagnosed as having narcolepsy with cataplexy are hypocretin ligand deficient. This has led to the development of new diagnostic tests (cerebrospinal fluid hypocretin-1 measurements). Hypocretin receptor agonists are likely to be ideal therapeutic options for hypocretin-deficient narcolepsy but such compounds are still not available in humans.
New developments in the management of narcolepsy. [2020]Narcolepsy is a life-long, underrecognized sleep disorder that affects 0.02%-0.18% of the US and Western European populations. Genetic predisposition is suspected because of narcolepsy's strong association with HLA DQB1*06-02, and genome-wide association studies have identified polymorphisms in T-cell receptor loci. Narcolepsy pathophysiology is linked to loss of signaling by hypocretin-producing neurons; an autoimmune etiology possibly triggered by some environmental agent may precipitate hypocretin neuronal loss. Current treatment modalities alleviate the main symptoms of excessive daytime somnolence (EDS) and cataplexy and, to a lesser extent, reduce nocturnal sleep disruption, hypnagogic hallucinations, and sleep paralysis. Sodium oxybate (SXB), a sodium salt of γ hydroxybutyric acid, is a first-line agent for cataplexy and EDS and may help sleep disruption, hypnagogic hallucinations, and sleep paralysis. Various antidepressant medications including norepinephrine serotonin reuptake inhibitors, selective serotonin reuptake inhibitors, and tricyclic antidepressants are second-line agents for treating cataplexy. In addition to SXB, modafinil and armodafinil are first-line agents to treat EDS. Second-line agents for EDS are stimulants such as methylphenidate and extended-release amphetamines. Emerging therapies include non-hypocretin-based therapy, hypocretin-based treatments, and immunotherapy to prevent hypocretin neuronal death. Non-hypocretin-based novel treatments for narcolepsy include pitolisant (BF2.649, tiprolisant); JZP-110 (ADX-N05) for EDS in adults; JZP 13-005 for children; JZP-386, a deuterated sodium oxybate oral suspension; FT 218 an extended-release formulation of SXB; and JNJ-17216498, a new formulation of modafinil. Clinical trials are investigating efficacy and safety of SXB, modafinil, and armodafinil in children. γ-amino butyric acid (GABA) modulation with GABAA receptor agonists clarithromycin and flumazenil may help daytime somnolence. Other drugs investigated include GABAB agonists (baclofen), melanin-concentrating hormone antagonist, and thyrotropin-releasing hormone agonists. Hypocretin-based therapies include hypocretin peptide replacement administered either through an intracerebroventricular route or intranasal route. Hypocretin neuronal transplant and transforming stem cells into hypothalamic neurons are also discussed in this article. Immunotherapy to prevent hypocretin neuronal death is reviewed.
National Estimates of Narcolepsy in Korea. [2023]Epidemiological data on narcolepsy are rare in South Korea. We aimed to provide an overview of the burden of narcolepsy and its temporal trend in South Korea.
Narcolepsy treatment: pharmacological and behavioral strategies in adults and children. [2021]Narcolepsy is a disabling, rare, and chronic sleep disorder, currently classified as distinct central nervous system hypersomnia in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Although today a reliable pathogenic hypothesis identifies the cause of NT1 as an autoimmune process destroying hypocretin-producing cells, there is no cure for narcolepsy, and the symptomatic pharmacological available treatments are not entirely effective for all symptoms. Behavioral therapies play a synergistic role in the disease treatment. We here review the available therapeutic options for narcolepsy, including symptomatic pharmacological treatments as well as behavioral and psychosocial interventions that could help clinicians improve the quality of life of patients with narcolepsy in adulthood and childhood.