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Compensation: Varies

Number of Visits: 2

Duration: 8-12 weeks

112 Participants Needed

TAK-861 for Narcolepsy

Recruiting at 65 trial locations

Overseen ByTakeda Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Disqualifiers: Hepatic disease, Thyroid disease, Cancer, Cardiac disease, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug TAK-861 different from other narcolepsy treatments?

TAK-861 is unique because it targets the orexin 2 receptor, which is involved in wakefulness, potentially offering a new approach to treating narcolepsy compared to traditional treatments that focus on managing symptoms like excessive daytime sleepiness and cataplexy.¹ ² ³ ⁴ ⁵

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 40.

You have been diagnosed with narcolepsy type 1 within the last 10 years using specific sleep tests.

The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF). (Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.)

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Exclusion Criteria

You have a significant heart condition such as heart disease, heart attack history, severe chest pain, abnormal heart rhythm, or heart failure.

The participant has medically significant hepatic or thyroid disease.

The participant has a clinically significant history of head injury or head trauma.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-861 or placebo for 8 or 12 weeks to evaluate efficacy, safety, and tolerability

8-12 weeks

Multiple visits to the clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, with 2 final visits 7 and 28 days after last dose

4 weeks

2 visits (in-person)

Open-label extension (optional)

Participants may opt into continuation of treatment with TAK-861 long-term

Treatment Details

Interventions

Placebo
TAK-861

Trial OverviewThe 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.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-861 7 mg QDExperimental Treatment2 Interventions

Participants received TAK-861 7 mg, orally, once daily (QD), from Day 1 to 56. Placebo was given as the second dose.

Group II: TAK-861 2 mg and 5 mgExperimental Treatment1 Intervention

Participants received TAK-861 2 mg followed by 5 mg dose, orally, BID, from Days 1 to 56.

Group III: TAK-861 2 mg BIDExperimental Treatment1 Intervention

Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

Group IV: TAK-861 0.5 mg BIDExperimental Treatment1 Intervention

Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.

Group V: PlaceboPlacebo Group1 Intervention

Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

TAK-925 is a selective agonist for the orexin 2 receptor (OX2R) that effectively promotes wakefulness in mice, indicating its potential as a treatment for narcolepsy and related sleep disorders.

The compound was developed through optimization of an earlier discovery and shows promise due to its ability to penetrate the brain and enhance wakefulness during sleep phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery of TAK-925 as a Potent, Selective, and Brain-Penetrant Orexin 2 Receptor Agonist.Fujimoto, T., Rikimaru, K., Fukuda, K., et al.[2022]

Narcolepsy affects a small percentage of the population and is linked to genetic factors and the loss of hypocretin-producing neurons, suggesting an autoimmune component that may be triggered by environmental factors.

Current treatments like sodium oxybate and modafinil effectively manage symptoms such as excessive daytime sleepiness and cataplexy, while emerging therapies focus on both non-hypocretin-based and hypocretin-based approaches to improve outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the management of narcolepsy.Abad, VC., Guilleminault, C.[2020]