A Study of TAK-861 in Participants With Narcolepsy Type 2

NCT ID: NCT05687916

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-12-25

Brief Summary

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).

The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

Detailed Description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy [Narcolepsy Type 2 (NT2)]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861.

The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• TAK-861 Dose 1
• TAK-861 Dose 2
• Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient

This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.

Conditions

Narcolepsy Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

TAK-861 placebo matching tablets.

TAK-861 2 milligrams (mg) BID

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

Group Type: EXPERIMENTAL

TAK-861 2 mg

Intervention Type: DRUG

TAK-861 2 mg tablets.

TAK-861 2 mg and 5 mg

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

Group Type: EXPERIMENTAL

TAK-861 2 mg and 5 mg

Intervention Type: DRUG

TAK-861 2 mg and 5 mg tablets.

Interventions

Placebo

TAK-861 placebo matching tablets.

Intervention Type: DRUG

TAK-861 2 mg

TAK-861 2 mg tablets.

Intervention Type: DRUG

TAK-861 2 mg and 5 mg

TAK-861 2 mg and 5 mg tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).

Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.

• The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.

Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.

Exclusion Criteria

• The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
• The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
• The participant has one or more of the following psychiatric disorders:

1. Any current unstable psychiatric disorder.

2. 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).

3. 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.)

4. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.

• The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
• The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Mayo Clinic Arizona-PPDS

Scottsdale, Arizona, United States

Stanford Center for Sleep Sciences and Medicine

Redwood City, California, United States

SDS Clinical Trials, Inc.

Santa Ana, California, United States

Delta Waves LLC - Hunt - PPDS

Colorado Springs, Colorado, United States

Florida Pediatric Research Institute

Orlando, Florida, United States

Neurotrials Research

Atlanta, Georgia, United States

Georgia Neuro Center

Gainesville, Georgia, United States

Neurocare Inc.

Newton, Massachusetts, United States

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

St. Lukes Sleep Medicine and Research Center

Chesterfield, Missouri, United States

Research Carolina Elite

Denver, North Carolina, United States

ARSM Research, LLC

Huntersville, North Carolina, United States

Tricoastal Narcolepsy and Sleep Disorders Center, PLLC

Cincinnati, Ohio, United States

Intrepid Research

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Sleep Medicine Institute

Dublin, Ohio, United States

Medical University of South Carolina - PPDS

Charleston, South Carolina, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

Comprehensive Sleep Medicine Associates - Sugar Land

Houston, Texas, United States

Sleep Therapy and Research Center

San Antonio, Texas, United States

Children's Specialty Group

Norfolk, Virginia, United States

Woolcock Institute of Medical Research

Glebe, New South Wales, Australia

Terveystalo Helsinki Sleep Clinic

Helsinki, Uusimaa, Finland

Hopital Saint-Eloi

Montpellier, Herault, France

CHU de Grenoble

La Tronche, Isere, France

Hopital de la Pitie Salpetriere

Paris, , France

Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, Germany

Advanced Sleep Research GmbH

Berlin, , Germany

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, Italy

Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Molise, Italy

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bellaria, , Italy

Akita University Hospital

Akita, Akita, Japan

Ehime University Hospital

Toon-Shi, Ehime, Japan

You Ariyoshi Sleep Clinic

Kitakyushu, Hukuoka, Japan

Kurume University Hospital

Kurume-Shi, Hukuoka, Japan

Howakai Kuwamizu Hospital

Kumamoto, Kumamoto, Japan

Gokeikai Osaka Kaisei Hospital

Osaka, Osaka, Japan

Koishikawa Tokyo Hospital

Bunkyo-Ku, Tokyo, Japan

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, Japan

Yoyogi Sleep Disorder Center

Shibuya-Ku, Tokyo, Japan

Aichi Medical University Hospital

Nagakute, , Japan

RESM respiratory and sleep medical-care clinic

Yokohama, , Japan

Kempenhaeghe - PPDS

Heeze, North Brabant, Netherlands

Slaap-Waakcentrum SEIN Heemstede

Heemstede, North Holland, Netherlands

Oslo Universitetssykehus HF Rikshospitalet

Oslo, , Norway

Hospital Universitario Araba Santiago

Vitoria-Gasteiz, Alava, Spain

Hospital General Universitari de Castello

Castellon, Castellon, Spain

Hospital de La Ribera

Alzira, Valencia, Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Instituto de Investigaciones del Sueno

Madrid, , Spain

Hospital Vithas Madrid Arturo Soria

Madrid, , Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, Sweden

Klinik Barmelweid AG

Barmelweid, Aargau (de), Switzerland

Neurocenter of Southern Switzerland

Lugano, Ticino (it), Switzerland

Universitaetsspital Bern - Inselspital

Bern, , Switzerland

Countries

United States; Australia; Finland; France; Germany; Italy; Japan; Netherlands; Norway; Spain; Sweden; Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/b8004ec7e72e4dd0?idFilter=%5B%22TAK-861-2002%22%5D

To obtain more information on the study, click here/on this link

Other Identifiers

2022-002966-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1282-8382

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031230050

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-861-2002

Identifier Type: -

Identifier Source: org_study_id