TAK-360 for Narcolepsy

Recruiting at 29 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

Trial Summary

What is the purpose of this trial?

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. 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 NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that 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.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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

Treatment Details

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.

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