JZP-258 for Narcolepsy

Phase-Based Estimates
3
Effectiveness
3
Safety
SDS Clinical Trials, Inc, Santa Ana, CA
Narcolepsy
JZP-258 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Narcolepsy

Study Summary

This study is evaluating whether a drug called XYWAV may be effective in treating narcolepsy.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether JZP-258 will improve 1 primary outcome and 9 secondary outcomes in patients with Narcolepsy. Measurement will happen over the course of Baseline to Week 8.

Baseline to Week 8
Change in Epworth Sleepiness Scale (ESS)
Change in Weekly Rate of Cataplexy Attacks
Change in the Nausea Visual Analog Scale (NVAS)
Characterization of Meals Relative to Dosing
Duration of time between the last meal relative to dosing
Number of Changes from the First Dose and Regimen to Optimized Dose and Regimen
Number of Participants Converted from Xyrem to XYWAV
Number of Participants Dosing Fasted Versus Dosing Without Consideration of Food
Time to Achieve Optimized Dose and Regimen
Week 8
Number of Participants with Participant Global Impression of Change (PGIc) Values

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

JZP-258
Headache
22%
Nausea
13%
Dizziness
11%
Cataplexy
10%
Nasopharyngitis
9%
Influenza
8%
Decreased appetite
7%
Diarrhoea
6%
Upper respiratory tract infection
5%
Somnolence
2%
Bile duct stone
0%
Viral cardiomyopathy
0%
Peripheral nerve paresis
0%
Confusional state
0%
Muscle enzyme increased
0%
Invasive ductal breast carcinoma
0%
Hallucination
0%
Accidental overdose
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03030599) in the JZP-258 ARM group. Side effects include: Headache with 22%, Nausea with 13%, Dizziness with 11%, Cataplexy with 10%, Nasopharyngitis with 9%.

Trial Design

2 Treatment Groups

Control
Open-Label Conversion and Treatment Optimization

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. JZP-258 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Open-Label Conversion and Treatment Optimization
Drug
Conversion from Xyrem to XYWAV, maintaining the dose and regimen of any concomitant anticataplectics or stimulants unchanged throughout study.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gamma-Hydroxybutyric acid
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 8 for reporting.

Closest Location

SDS Clinical Trials, Inc - Santa Ana, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant must be 18 to 80 years of age (inclusive), at the time of signing the informed consent. Type of Participant and Disease Characteristics
Participants who have a primary diagnosis of Type 1 or Type 2 narcolepsy that meets ICSD-3 criteria or DSM-5 criteria (Ruoff and Rye 2016), and are being currently treated with Xyrem, with or without additional anticataplectics or stimulants.
Sex and Contraceptive/Barrier Requirements
Participant is male or female
Age
Participants who have been taking Xyrem (with or without additional anticataplectics or stimulants eg, TCA, SNRI, SSRI, atomoxetine) in a stable dose and regimen for at least two months prior to screening, with evidence of clinical improvement on their current regimen, per the investigator's judgement. Only Xyrem will be substituted with XYWAV, with dose and regimen of any concomitant anticataplectics or stimulants remaining unchanged throughout the study.
Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 3 OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of < 1% per year), preferably with low user dependency, as described in Appendix 3, during the study Intervention period and for at least 7 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.
A WOCBP must have a negative highly sensitive pregnancy test (serum) during screening.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Informed Consent

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is narcolepsy?

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In our sample, the incidence of Narcolepsy was approximately 4.7% in our population. The gender incidence ratio was 1.07; the age incidence rate was 63 + 16 yr. and the mean age was 44 yr. There was no familial occurrence of Narcolepsy. To the authors' knowledge, this is the first report of the occurrence of Narcolepsy in a general population of Indians.

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How many people get narcolepsy a year in the United States?

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About 100,950 people in the United States are diagnosed with narcolepsy. A major cause of sleepiness is central sleep apnea as seen in narcolepsy. To prevent narcolepsy, treatment of narcolepsy should be initiated in childhood.

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Can narcolepsy be cured?

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Narcolepsy can be highly severe, and while some patients can be treated effectively and sustain a long-term remission, others have no response to pharmacological therapy, and may be advised to adopt a life-long medical and behavioral approach.

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What causes narcolepsy?

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Sleep-disordered breathing is a common, treatable pathologic manifestation of narcolepsy. The narcolepsy-cataplexy syndrome shares a common pathogenesis with other narcolepsy symptoms, such as excessive daytime sleepiness, hypersomnia, and hypnagogic hallucinations. These symptoms, though different features of narcolepsy disease presentation, may indicate a common underlying pathophysiology.

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What are common treatments for narcolepsy?

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Many patients have comorbid anxiety or depression. Treatment should be customized to each patient's specific needs. Sleep medicine is focused on treating the individual's daytime sleepiness and controlling the symptoms of the disorder. This includes managing symptoms and optimizing compliance with sleep medications. Cognitive behavioral therapy is used to reduce or eliminate avoidance of the symptom triggering triggers of narcolepsy. Medications used to control comorbid symptoms include stimulants such as methylphenidate. Sleep hygiene can be addressed through the following: sleep hygiene education, sleep hygiene counseling, and sleep hygiene education on the importance of adherence to sleep hygiene recommendations.

Unverified Answer

What are the signs of narcolepsy?

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The signs of narcolepsy are fatigue, hypersomnia, and cataplexy. It is important to recognize the symptoms of narcolepsy among all patients admitted to the intensive care department for one week. Narcolepsy is a multisystem disease with many possible symptoms such as headaches, irritability, vomiting, and depression.

Unverified Answer

Who should consider clinical trials for narcolepsy?

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Clinical trials should be run as part of patient education for people with narcolepsy as a part of the management of chronic disabling sleepiness. The primary goal of narcolepsy trials is to determine if any treatment can prevent the development of cataplexy and/or enhance the recovery time after a cataplexy attack. Clinical trials should also evaluate for an effect on sleep quality, alertness, mood, cognition, and energy level in narcoleptics with normal sleepiness who have moderate to severe disabling sleepiness of several months' duration.

Unverified Answer

Is jzp-258 safe for people?

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A large dose of Jzp-258 was safe. There were only one or two symptomatic patients, and no serious adverse effects in any of the other patients on that study. The only side-effect reported was mild nasal congestion. Neither the authors nor the manufacturer have any other data. They are unaware of any previous studies of these same patients.

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Does jzp-258 improve quality of life for those with narcolepsy?

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This proof-of-concept study demonstrated a significantly improved quality of life in response to Jzp-258 treatment versus placebo treatment. Jzp-258 should gain interest from researchers as a potential therapeutic agent for patients with narcolepsy who have reported a reduction in the severity of their sleep impairment and an improvement in the amount and quality of sleep while using the current pharmacological treatment of sleepiness.

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How serious can narcolepsy be?

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Narcolepsy is serious and life-threatening. Patients and treatment providers must be aware that narcolepsy can be fatal. Narcolepsy patients tend to die in four main situations: overdose of medication; suicide; motor vehicle accidents; and (rarely) suicide by jumping. It is important to be aware of potential complications and treatment options so that patients can keep their sleep habits as well as their quality of life balanced. Patients with Narcolepsy are at risk for a variety of other serious adverse health effects. For a select group of patients who may be considered at heightened risk, a more proactive approach may be reasonable, considering the potential risks.

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Has jzp-258 proven to be more effective than a placebo?

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Jzp-258 was shown to be more effective than placebo in enhancing daytime sleepiness in patients with narcolepsy, providing further evidence that the CNT is a viable therapeutic target.

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What is the latest research for narcolepsy?

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Since there is no cure for narcolepsy, there are many treatments to control symptoms and help patients live better. In narcolepsy, there are two ways to diagnose: clinical and objective sleep study. Narcolepsy is more diagnosed in males than in females. Treatment options are medication, surgery and behavioral intervention. Some medications used include MCT/BCT, adderall, and medication options such as modafinil, yohimbine, and naltrexone. Narcolepsy may be mistaken for the REM sleep behavior disorder.\n\nHypersomnia: The first case of hypersomnia was first described and named by John F. Clark in 1962 by Clark et al.

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