TAK-360 for Excessive Daytime Sleepiness

Recruiting at 32 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Disqualifiers: Thyroid disease, Cancer, Viral infections, 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 a new treatment called TAK-360, designed to help individuals with Idiopathic Hypersomnia (IH) feel less sleepy during the day. IH causes excessive sleepiness despite adequate nighttime sleep, making it difficult to wake up and stay awake. TAK-360 mimics orexin, a brain chemical that promotes wakefulness. Participants will receive either TAK-360 or a placebo (a pill resembling the medicine but without active ingredients) for 4 weeks. This trial may suit those with a current IH diagnosis and no other medical disorder causing daytime sleepiness. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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?

Research shows that TAK-360 is under careful study for its safety in treating idiopathic hypersomnia (IH), a condition causing excessive daytime sleepiness. Earlier studies have demonstrated that drugs like TAK-360, which mimic a brain chemical called orexin, help people stay awake during the day. These studies aim to determine TAK-360's safety and tolerability.

Since the current study is in the early stages, complete safety data is not yet available. However, TAK-360's current testing suggests it showed promise in earlier research. Treatments in this phase typically have already demonstrated some safety in initial studies before being tested on more people.

The ongoing research primarily aims to ensure TAK-360 is both effective and safe for people with IH. Researchers closely monitor participants to track any side effects and assess how well they tolerate the treatment. ^{1 2 3 4 5}

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

Most treatments for excessive daytime sleepiness, like modafinil and armodafinil, work by stimulating the brain to promote wakefulness. But TAK-360 works differently, targeting specific receptors in the brain that help regulate our sleep-wake cycle more precisely. Researchers are excited about TAK-360 because it promises fewer side effects and potentially better alignment with our natural sleep patterns compared to current options. This unique approach could offer a more balanced and effective solution for those struggling with daytime drowsiness.

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

Research has shown that TAK-360 might help people with Idiopathic Hypersomnia (IH) stay awake. Medicines like TAK-360, which mimic orexin (a brain chemical that helps maintain alertness), have shown promise in reducing excessive daytime sleepiness. Similar studies have demonstrated significant improvements in wakefulness with these medicines. Although specific data on TAK-360 for IH is limited, early results appear promising. In this trial, participants will receive either TAK-360 or a placebo to assess tolerance and determine the appropriate dosage needed to manage symptoms effectively. ^{1 4 6 7 8}

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 Idiopathic Hypersomnia (IH), a condition causing extreme daytime sleepiness and difficulty waking up. Participants must weigh at least 40 kg, have a BMI between 16 and 38 kg/m^2, and have a current diagnosis of IH.

Inclusion Criteria

I have been diagnosed with IH.

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

Exclusion Criteria

I have a condition causing excessive daytime sleepiness, not IH.

I have a serious thyroid condition.

I had cancer within the last 5 years, with some exceptions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 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 people stay awake. It will be compared to a placebo (no active medicine) to determine its safety, tolerability, and effective dosage for improving wakefulness in IH 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/NCT06812078

A Study of TAK-360 in Adults With Idiopathic Hypersomnia The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH]. The participant has medically significant ...

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 ... Wakefulness: Oveporexton improved excessive daytime sleepiness demonstrating statistically significant improvement from baseline in mean sleep ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-tak-360-for-patients-with-idiopathic-hypersomnia/

Study of TAK-360 tablets to evaluate safety and ... The purpose of this research is to determine if TAK-360 is safe and well-tolerated by people with Idiopathic Hypersomnia. The study will compare TAK-360 tablets ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06952699

NCT06952699 | A Study of TAK-360 in Adults With ... Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. Baseline, Week 4. Change from ...

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

A Study of TAK-360 in Adults With Narcolepsy Without ... Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. Time frame.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06812078

A Study of TAK-360 in Adults With Idiopathic Hypersomnia The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-tak-360-in-adults-with-idiopathic-hypersomnia

A Study of TAK-360 in Adults With Idiopathic Hypersomnia TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.

8. withpower.com withpower.com/trial/phase-2-disorders-of-excessive-somnolence-1-2025-a2eaa

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