What side effects are associated with this type of intervention?

Common treatments for narcolepsy, particularly those similar to TAK-861 (an Orexin Receptor Agonist), often have side effects such as headache, somnolence, and potential liver function abnormalities. Other narcolepsy medications, including stimulants, sodium oxybate, and antidepressants, may cause insomnia, anxiety, nausea, and dizziness. 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 treatments for narcolepsy, including sodium oxybate, which is used to treat excessive daytime sleepiness and cataplexy. Sodium oxybate works by modulating neurotransmitter activity to improve sleep quality. While TAK-861 is an orexin receptor agonist, which is a newer class of drugs targeting the orexin system to promote wakefulness, there are currently no FDA-approved orexin receptor agonists specifically for narcolepsy. Other treatments for narcolepsy include stimulants like modafinil and armodafinil, which promote wakefulness through different mechanisms.

What other types of research exist?

Promising novel alternatives to TAK-861 for narcolepsy patients include TAK-925, an orexin 2 receptor-selective agonist, and compound 33 b, a novel N-aryl-2-phenylcyclopropanecarboxamide with potent in vitro activity and oral efficacy in animal studies.

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TAK-861 for Narcolepsy

Phase 2 & 3

Recruiting

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 from signing the informed consent form up to follow-up of 4 weeks after the last dose (up to approximately 5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing TAK-861, a new drug, on people with type 1 and type 2 narcolepsy. The goal is to see if it can help reduce excessive daytime sleepiness and sudden muscle weakness. The study will involve up to 160 participants from previous studies and will last about two years.

Who is the study for?

This trial is for people with narcolepsy who have already taken TAK-861 in earlier studies without serious side effects. They shouldn't have other sleep disorders, major depression recently, digestive issues affecting drug absorption, seizures, significant heart or liver diseases, recent strokes or cancer within the last 5 years.

What is being tested?

The study tests the safety and tolerability of a drug called TAK-861 on individuals with type 1 and type 2 narcolepsy who participated in previous related trials. It aims to understand how well these patients can handle continued treatment.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to TAK-861 that they may experience during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from signing the informed consent form up to follow-up of 4 weeks after the last dose (up to approximately 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from signing the informed consent form up to follow-up of 4 weeks after the last dose (up to approximately 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from signing the informed consent form up to follow-up of 4 weeks after the last dose (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score

Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)

Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TAK-861 Dose 2Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 2 for up to approximately 5 years.

Group II: TAK-861 Dose 1Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 1 for up to approximately 5 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-861

2023

Completed Phase 2

~190

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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 include stimulants like modafinil and amphetamines, which promote wakefulness by increasing dopamine and norepinephrine levels. Sodium oxybate, another treatment, improves nighttime sleep and reduces daytime sleepiness by acting on GABA receptors. Orexin receptor agonists, such as TAK-861, mimic the action of orexin, a neuropeptide that regulates wakefulness and arousal. This is particularly important for narcolepsy patients, as the condition often involves a deficiency in orexin, leading to excessive daytime sleepiness and cataplexy. By targeting the underlying orexin deficiency, orexin receptor agonists offer a more direct approach to managing narcolepsy symptoms.

Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysis.Sleep medicine pharmacotherapeutics overview: today, tomorrow, and the future (Part 1: insomnia and circadian rhythm disorders).Pharmacotherapy of insomnia.