What side effects are associated with this type of intervention?

Common treatments for narcolepsy, such as modafinil, armodafinil, sodium oxybate, solriamfetol, and pitolisant, aim to reduce excessive daytime sleepiness. Known side effects include headache, nausea, anxiety, dizziness, and insomnia. Sodium oxybate may also cause enuresis, confusion, and sleepwalking. Individual responses to these medications can vary, so side effects should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of narcolepsy, primarily targeting excessive daytime sleepiness (EDS). These include stimulants like modafinil and armodafinil, which promote wakefulness, and sodium oxybate, which helps regulate sleep patterns. Additionally, solriamfetol, a dopamine and norepinephrine reuptake inhibitor, has been approved to improve wakefulness in patients with narcolepsy. These treatments aim to manage symptoms similar to those being studied in the TAK-861 trial.

What other types of research exist?

Promising alternatives to TAK-861 for narcolepsy treatment include: <ol> <li>Lemborexant: A dual orexin receptor antagonist (DORA) shown to be effective in treating insomnia, which may also help with EDS in narcolepsy.</li> <li></li> </ol> Daridorexant: Another DORA that has demonstrated efficacy in treating insomnia and could be beneficial for narcolepsy patients. 3. E2006: An orally active, potent orexin receptor antagonist that has shown efficacy in animal sleep studies and could be a potential treatment for narcolepsy.

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Placebo

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 from baseline up to approximately 12 weeks

Awards & highlights

Summary

This trial will test a new treatment for narcolepsy to see if it helps reduce excessive daytime sleepiness. It will involve 60 people in 3 groups (20 each) in North America, Europe, and Asia Pacific.

Who is the study for?

Adults aged 18-70 with a diagnosis of Narcolepsy Type 2 (NT2) can join this trial. They must have had a sleep study in the last 5 years confirming NT2, or they may undergo another one if needed. People with other disorders causing excessive daytime sleepiness, certain psychiatric conditions, substance use disorders, or recent major surgery are not eligible.Check my eligibility

What is being tested?

The trial is testing TAK-861 to see if it helps with narcolepsy symptoms like staying awake during the day. Participants will be randomly placed into three groups to receive either TAK-861 at two different doses or a placebo for eight weeks and complete questionnaires about their condition.See study design

What are the potential side effects?

While specific side effects of TAK-861 aren't listed here, 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 ~ from baseline up to approximately 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to approximately 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

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

Secondary outcome measures

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

Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-861 Dose 2Experimental Treatment1 Intervention

TAK-861 dose 2, orally for 8 weeks.

Group II: TAK-861 Dose 1Experimental Treatment1 Intervention

TAK-861 dose 1, orally for 8 weeks.

Group III: PlaceboPlacebo Group1 Intervention

TAK-861 matching placebo tablets, orally for 8 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 primarily aim to alleviate excessive daytime sleepiness (EDS) and include stimulants like modafinil and amphetamines, which increase dopamine levels to promote wakefulness. Wakefulness-promoting agents such as armodafinil and pitolisant work by enhancing histamine signaling in the brain. Sodium oxybate, another treatment, improves nighttime sleep, thereby reducing daytime sleepiness. These mechanisms are crucial for narcolepsy patients as they help manage the debilitating symptoms of EDS, improving daily functioning and quality of life. TAK-861, while its specific mechanism is not detailed, likely targets similar pathways to enhance wakefulness and manage EDS.

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Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,213 Previous Clinical Trials

4,187,082 Total Patients Enrolled

8 Trials studying Narcolepsy

929 Patients Enrolled for Narcolepsy

Study DirectorStudy DirectorTakeda

1,230 Previous Clinical Trials

501,019 Total Patients Enrolled

5 Trials studying Narcolepsy

570 Patients Enrolled for Narcolepsy

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05687916 — Phase 2

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

Narcolepsy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05687916 — Phase 2

Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05687916 — Phase 2

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