TAK-360 for Excessive Daytime Sleepiness

Recruiting at 28 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

Trial Summary

What is the purpose of this trial?

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. 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 people with IH stay awake and how much TAK-360 is needed to do that. Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

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.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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