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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Other

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 baseline (parent study); week 10 through week 105 (current lte study)

Awards & highlights

Summary

This trial studies the safety of a new drug for people with narcolepsy, a sleep disorder.

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.Check my eligibility

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.See study design

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 ~ baseline (parent study); week 10 through week 105 (current lte study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (parent study); week 10 through week 105 (current lte study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (parent study); week 10 through week 105 (current lte study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 for Participants With NT1

Trial Design

4Treatment groups

Experimental Treatment

Group I: TAK-861 Dose 4Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 4 for up to 104 weeks.

Group II: TAK-861 Dose 3Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 3 for up to 104 weeks.

Group III: TAK-861 Dose 2Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 2 for up to 104 weeks.

Group IV: TAK-861 Dose 1Experimental Treatment1 Intervention

Participants will receive TAK-861 dose 1 for up to 104 weeks.

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 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.

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,213 Previous Clinical Trials

4,186,993 Total Patients Enrolled

8 Trials studying Narcolepsy

840 Patients Enrolled for Narcolepsy

Study DirectorStudy DirectorTakeda

1,230 Previous Clinical Trials

500,930 Total Patients Enrolled

5 Trials studying Narcolepsy

481 Patients Enrolled for Narcolepsy

Media Library

TAK-861 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05816382 — Phase 2 & 3

Narcolepsy Research Study Groups: TAK-861 Dose 1, TAK-861 Dose 2, TAK-861 Dose 3, TAK-861 Dose 4

Narcolepsy Clinical Trial 2023: TAK-861 Highlights & Side Effects. Trial Name: NCT05816382 — Phase 2 & 3

TAK-861 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05816382 — Phase 2 & 3

~105 spots leftby Dec 2026

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