TAK-360 for Excessive Daytime Sleepiness

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Takeda

Prior Safety Data

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.

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

I have been diagnosed with IH.

Exclusion Criteria

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

I have a serious thyroid condition.

I have had a stroke, mini-stroke, brain aneurysm, or blood vessel malformation in the last 5 years.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TAK-360Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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