TAK-360 for Narcolepsy

Recruiting at 42 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Disqualifiers: Other sleep disorders, Thyroid disease, Cancer, Viral infections, Head injury, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests TAK-360, a new treatment for Narcolepsy Type 2 (NT2), a condition causing extreme daytime sleepiness. The study aims to determine the safety, tolerability, and effectiveness of TAK-360 in helping participants stay awake. Participants will be randomly assigned to receive either TAK-360 or a placebo (a pill without active medicine) to compare effects. This trial is for adults with a current NT2 diagnosis who do not have other medical conditions causing excessive daytime sleepiness. As a Phase 2 trial, this research measures TAK-360's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that TAK-360 is likely to be safe for humans?

Previous studies have shown that TAK-360 is generally well-tolerated by patients. Research indicates that similar medicines, which act on orexin, did not cause any serious treatment-related side effects. Common issues included trouble sleeping and increased urination, but these were anticipated based on earlier findings and were not considered severe. This suggests that TAK-360 might be a safe option for people with narcolepsy without cataplexy, although further information is needed to confirm its long-term safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for narcolepsy?

TAK-360 is unique because it offers a new approach to treating narcolepsy by targeting pathways that current treatments, like modafinil or sodium oxybate, might not address. Unlike these treatments, which primarily focus on promoting wakefulness or inducing sleep, TAK-360 could potentially provide a more balanced regulation of sleep-wake cycles. Researchers are excited about TAK-360 because it might offer improved symptom control with possibly fewer side effects, making it a promising option for patients who need better management of their condition.

What evidence suggests that TAK-360 might be an effective treatment for narcolepsy?

Research has shown that treatments similar to orexin, a brain chemical that promotes wakefulness, might help people stay alert. TAK-360, which participants in this trial may receive, is one such treatment. Since orexin maintains alertness, TAK-360 could benefit individuals with narcolepsy type 2, a condition causing extreme daytime sleepiness. Although specific data on TAK-360's effectiveness in human trials is limited, similar treatments have successfully helped people stay awake and reduce daytime sleepiness. This offers hope that TAK-360 might be effective for those with narcolepsy type 2. ^{1 2 3 4 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for adults with Narcolepsy Type 2 (NT2), a condition causing excessive daytime sleepiness without cataplexy. Participants must weigh at least 40 kg and have a BMI between 16-38 kg/m^2. They should have a confirmed diagnosis of NT2.

Inclusion Criteria

I weigh at least 40 kg and my BMI is between 16 and 38.

I have been diagnosed with Narcolepsy Type 2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TAK-360 or placebo tablets orally for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAK-360

Trial Overview The study tests TAK-360, which mimics the brain chemical orexin to help keep people awake, against a placebo (a pill with no medicine). The goal is to determine TAK-360's safety, tolerability, effective dosage, and its ability to improve wakefulness in NT2 patients.

How Is the Trial Designed?

Group I: TAK-360 Experimental Treatment 1 Intervention

Participants will receive TAK-360 tablets, orally, for 4 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive TAK-360 matching-placebo tablets, orally, for 4 weeks.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06952699

NCT06952699 | A Study of TAK-360 in Adults With ... These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior ...

2. takeda.com takeda.com/newsroom/newsreleases/2025/takeda-orexin-data-oveporexton-phase-3-narcolepsy-world-sleep-2025/

Takeda Presents Orexin Data from Landmark Oveporexton ... Discover how Takeda's Oveporexton (TAK-861) Phase 3 studies reveal significant improvements in narcolepsy type 1 symptoms, marking a ...

3. nature.com nature.com/articles/d41573-025-00137-4

Leading orexin receptor agonist clears phase III for ... The trials also met secondary endpoints measuring objective and patient-reported improvements in wakefulness, excessive daytime sleepiness, ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/603790

A Study of TAK-360 in Adults With Narcolepsy Without ... The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help ...

5. labiotech.eu labiotech.eu/in-depth/new-narcolepsy-treatments/

New narcolepsy treatments: pipeline drugs to watch in 2025 In fact, 72% of the patients achieved at least a 50% improvement in cataplexy after a month and an 82% reduction at six months. It also led to ...

6. withpower.com withpower.com/trial/tak-360-for-narcolepsy-10d59

TAK-360 for Narcolepsy This Phase 2 medical study run by Takeda is evaluating whether TAK-360 will have tolerable side effects & efficacy for patients with Narcolepsy.