TAK-861 for Narcolepsy

Recruiting at 56 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Takeda

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing TAK-861, a new drug, to help people with Narcolepsy Type 2 stay awake during the day. The study will measure how well the drug works by seeing if it helps participants stay awake longer. About 60 people will take part in this study, which will last several months.

Research Team

Medical Director

Principal Investigator

Takeda

Eligibility Criteria

Adults aged 18-70 with a diagnosis of Narcolepsy Type 2 (NT2) can join this trial. They must have had a sleep study in the last 5 years confirming NT2, or they may undergo another one if needed. People with other disorders causing excessive daytime sleepiness, certain psychiatric conditions, substance use disorders, or recent major surgery are not eligible.

Inclusion Criteria

I am between 18 and 70 years old.

I have been diagnosed with narcolepsy type 2 in the last 5 years.

Exclusion Criteria

I have a condition causing excessive daytime sleepiness, not including narcolepsy without cataplexy.

The participant has one or more of the following psychiatric disorders: Any current unstable psychiatric disorder, current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), current diagnosis or history of substance use disorder as defined in the DSM-5. (Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.), current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.

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

Treatment Details

Interventions

• Placebo (Placebo)
• TAK-861 (Unknown)

Trial Overview The trial is testing TAK-861 to see if it helps with narcolepsy symptoms like staying awake during the day. Participants will be randomly placed into three groups to receive either TAK-861 at two different doses or a placebo for eight weeks and complete questionnaires about their condition.

Participant Groups

Group I: TAK-861 2 milligrams (mg) BID Experimental Treatment 1 Intervention

Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.

Group II: TAK-861 2 mg and 5 mg Experimental Treatment 1 Intervention

Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.

Group III: Placebo Placebo Group 1 Intervention

Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.

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