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

NCT05687916 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: TAK-861-20022022-002966-34U1111-1282-8382jRCT2031230050
• Study Type: interventional
• Target: 71
• Locations: 12 countries
• Sites: 56

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.

Conditions

Narcolepsy Type 2

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8

  The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.

  Baseline, Week 8

Secondary Outcomes (2)

• Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8

  Baseline, Week 8

• Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)

  From first dose of the study drug up to end of the study (up to 3 months)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

TAK-861 2 milligrams (mg) BID

EXPERIMENTAL

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

Drug: TAK-861 2 mg

TAK-861 2 mg and 5 mg

EXPERIMENTAL

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

Drug: TAK-861 2 mg and 5 mg

Interventions

Placebo DRUG

TAK-861 placebo matching tablets.

Placebo

TAK-861 2 mg DRUG

TAK-861 2 mg tablets.

TAK-861 2 milligrams (mg) BID

TAK-861 2 mg and 5 mg DRUG

TAK-861 2 mg and 5 mg tablets.

TAK-861 2 mg and 5 mg

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (56)

Sleep Disorders Center of Alabama

Birmingham, Alabama, 35213-1966, United States

Location

Mayo Clinic Arizona-PPDS

Scottsdale, Arizona, 85259-5452, United States

Location

Stanford Center for Sleep Sciences and Medicine

Redwood City, California, 94063, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705-8519, United States

Location

Delta Waves LLC - Hunt - PPDS

Colorado Springs, Colorado, 80918, United States

Location

Florida Pediatric Research Institute

Orlando, Florida, 32803-1468, United States

Location

Neurotrials Research

Atlanta, Georgia, 30342-1743, United States

Location

Georgia Neuro Center

Gainesville, Georgia, 30501-3883, United States

Location

Neurocare Inc.

Newton, Massachusetts, 02459, United States

Location

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Location

St. Lukes Sleep Medicine and Research Center

Chesterfield, Missouri, 63017-3406, United States

Location

Research Carolina Elite

Denver, North Carolina, 28037, United States

Location

ARSM Research, LLC

Huntersville, North Carolina, 28078-5082, United States

Location

Tricoastal Narcolepsy and Sleep Disorders Center, PLLC

Cincinnati, Ohio, 45212, United States

Location

Intrepid Research

Cincinnati, Ohio, 45227-2172, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017-3521, United States

Location

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425-5712, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201-2923, United States

Location

Comprehensive Sleep Medicine Associates - Sugar Land

Houston, Texas, 77030-2042, United States

Location

Sleep Therapy and Research Center

San Antonio, Texas, 78229-4849, United States

Location

Children's Specialty Group

Norfolk, Virginia, 23510-1021, United States

Location

Woolcock Institute of Medical Research

Glebe, New South Wales, 2037, Australia

Location

Terveystalo Helsinki Sleep Clinic

Helsinki, Uusimaa, 00380, Finland

Location

Hopital Saint-Eloi

Montpellier, Herault, 34090, France

Location

CHU de Grenoble

La Tronche, Isere, 38700, France

Location

Hopital de la Pitie Salpetriere

Paris, 75013, France

Location

Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

Advanced Sleep Research GmbH

Berlin, 10117, Germany

Location

Fondazione PTV Policlinico Tor Vergata

Rome, Lazio, 00133, Italy

Location

Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Molise, 86077, Italy

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bellaria, 40139, Italy

Location

Akita University Hospital

Akita, Akita, 010-8543, Japan

Location

Ehime University Hospital

Toon-Shi, Ehime, 791-0295, Japan

Location

You Ariyoshi Sleep Clinic

Kitakyushu, Hukuoka, 806-0021, Japan

Location

Kurume University Hospital

Kurume-Shi, Hukuoka, 830-0011, Japan

Location

Howakai Kuwamizu Hospital

Kumamoto, Kumamoto, 862-0954, Japan

Location

Gokeikai Osaka Kaisei Hospital

Osaka, Osaka, 532-0003, Japan

Location

Koishikawa Tokyo Hospital

Bunkyo-Ku, Tokyo, 112-0012, Japan

Location

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, 187-8551, Japan

Location

Yoyogi Sleep Disorder Center

Shibuya-Ku, Tokyo, 151-0053, Japan

Location

Aichi Medical University Hospital

Nagakute, 480-1195, Japan

Location

RESM respiratory and sleep medical-care clinic

Yokohama, 222-0033, Japan

Location

Kempenhaeghe - PPDS

Heeze, North Brabant, 5591 VE, Netherlands

Location

Slaap-Waakcentrum SEIN Heemstede

Heemstede, North Holland, 2103 SW, Netherlands

Location

Oslo Universitetssykehus HF Rikshospitalet

Oslo, 0450, Norway

Location

Hospital Universitario Araba Santiago

Vitoria-Gasteiz, Alava, 1004, Spain

Location

Hospital General Universitari de Castello

Castellon, Castellon, 12004, Spain

Location

Hospital de La Ribera

Alzira, Valencia, 46600, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Instituto de Investigaciones del Sueno

Madrid, 28036, Spain

Location

Hospital Vithas Madrid Arturo Soria

Madrid, 28043, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götaland County, 413 90, Sweden

Location

Klinik Barmelweid AG

Barmelweid, Aargau (de), 5017, Switzerland

Location

Neurocenter of Southern Switzerland

Lugano, Ticino (it), 6900, Switzerland

Location

Universitaetsspital Bern - Inselspital

Bern, 3010, Switzerland

Location

Related Links

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

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: January 9, 2023
• Primary Completion: December 13, 2023
• Study Completion: December 25, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

FR (3); AU (1); NL (2); US (22); JP (11); CH (3); DE (2); NO (1); IT (3); ES (6); SE (1); FI (1)