What side effects are associated with this type of intervention?

Common treatments for narcolepsy, such as JZP-110, often target central nervous system effects to alleviate symptoms like excessive daytime sleepiness and cataplexy. Known side effects of JZP-110 include nausea, noncardiac chest discomfort, and headache. Other treatments for narcolepsy may have similar side effects, including dizziness, dry mouth, and insomnia. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of narcolepsy, primarily targeting excessive daytime sleepiness and cataplexy. These include stimulants like modafinil and armodafinil, which promote wakefulness, and sodium oxybate, which is effective for both excessive daytime sleepiness and cataplexy. Additionally, pitolisant, a histamine H3 receptor antagonist/inverse agonist, and solriamfetol, a dopamine and norepinephrine reuptake inhibitor, have been approved for managing excessive daytime sleepiness in narcolepsy patients. These treatments, like TAK-861, aim to modulate central nervous system activity to alleviate symptoms.

What other types of research exist?

Promising alternatives to TAK-861 for narcolepsy patients include: <ol> <li>Lemborexant: A dual orexin receptor antagonist that has shown efficacy in improving sleep parameters and is well-tolerated over long-term use.</li> <li></li> </ol> Daridorexant: Another dual orexin receptor antagonist that has demonstrated safety and efficacy in treating insomnia, which may also benefit narcolepsy patients. 3. Cannabinoids: These have shown favorable effects on sleep quality in short-term studies and may offer benefits for managing sleep-related symptoms in narcolepsy.

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Unknown

TAK-861 for Narcolepsy

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 16 weeks

Summary

This trial is testing a new drug called TAK-861 to see if it can help people with narcolepsy feel less sleepy during the day and have fewer episodes of sudden muscle weakness. The study will include about 100 participants from different parts of the world.

Who is the study for?

Adults aged 18-70 with narcolepsy type 1 confirmed by sleep tests, a BMI of 18-40 kg/m^2, and specific genetic markers or low levels of the brain hormone orexin. Excluded are those with significant medical conditions like heart disease, liver or thyroid issues, history of cancer within five years (except certain skin cancers), head trauma, seizures, stroke risks, infectious diseases like hepatitis B/C or HIV, poor kidney function or high liver enzyme levels.

What is being tested?

The study is testing TAK-861 to see if it improves daytime sleepiness and cataplexy in people with narcolepsy. Participants will randomly receive either TAK-861 or a placebo for up to 12 weeks across various regions globally. Afterward, they may join an extension study where everyone gets TAK-861.

What are the potential side effects?

While the trial doesn't explicitly list side effects for TAK-861 since it's under investigation, common side effects for narcolepsy medications can include headache, nausea, dizziness and irritability. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)

Secondary study objectives

Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score

Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-861 Dose 4Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 4, orally, from Day 1 up to Weeks 8 or 12.

Group II: TAK-861 Dose 3Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 3, orally, from Day 1 up to Weeks 8 or 12.

Group III: TAK-861 Dose 2Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 2, orally, from Day 1 up to Weeks 8 or 12.

Group IV: TAK-861 Dose 1Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 1, orally, from Day 1 up to Weeks 8 or 12.

Group V: PlaceboPlacebo Group1 Intervention

Participants will receive TAK-861 matching placebo tablets, orally, from Day 1 up to Weeks 8 or 12.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-861

2023

Completed Phase 2

~190

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Narcolepsy often target the central nervous system to alleviate symptoms such as excessive daytime sleepiness and cataplexy. Stimulants like modafinil and amphetamines increase wakefulness by enhancing dopamine and norepinephrine activity. Sodium oxybate, another treatment, improves nighttime sleep and reduces cataplexy by acting on GABA receptors. Orexin receptor agonists, such as TAK-861, aim to mimic the action of orexin, a neuropeptide that regulates wakefulness and REM sleep. These treatments are crucial for Narcolepsy patients as they address the underlying neurochemical imbalances, thereby improving daily functioning and quality of life.

[Roles of orexin and effects of orexin receptor antagonists].The effect of insomnia definitions, terminology, and classifications on clinical practice.