A Study of TAK-861 for the Treatment of Narcolepsy Type 1

NCT06470828 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: TAK-861-30012023-508465-32-00jRCT2051240083
• Study Type: interventional
• Target: 168
• Locations: 11 countries
• Sites: 53

Brief Summary

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861.

Conditions

Narcolepsy Type 1

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in Mean Sleep Latency From the 4 Maintenance of Wakefulness Test (MWT) Wake Trials

  The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.

  Baseline, Week 12

Secondary Outcomes (8)

• Change From Baseline to Week 12 in ESS Total Score

  Baseline, Week 12

• Weekly Cataplexy Rate (WCR) at Week 12

  Week 12

• Change From Baseline to Week 12 in Mean Number of Lapses on the 3 Psychomotor Vigilance Test (PVT)

  Baseline, Week 12

• Patient Global Impression of Change (PGI-C) Score at Week 12

  Week 12

• Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score

  Baseline, Week 12

Study Arms (3)

TAK-861 Dose 1

EXPERIMENTAL

Participants will receive TAK-861 tablets at dose 1, orally, for 12 weeks.

Drug: TAK-861

TAK-861 Dose 2

EXPERIMENTAL

Participants will receive TAK-861 tablets at dose 2, orally, for 12 weeks.

Drug: TAK-861

Placebo

PLACEBO COMPARATOR

Participants will receive TAK-861-matching placebo tablets, orally, for 12 weeks.

Drug: Placebo

Interventions

TAK-861 DRUG

Oral tablet.

TAK-861 Dose 1; TAK-861 Dose 2

Placebo DRUG

TAK-861-matching placebo tablet.

Placebo

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 has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^2).
• The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
• The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
• The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\].

You may not qualify if:

• The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
• The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
• The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
• The participant has a history of cancer in the past 5 years.
• The participant has a clinically significant history of head injury or head trauma.
• The participant has a history of epilepsy, seizure, or convulsion.
• The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Sponsors & Collaborators

• Takeda: lead

Study Sites (53)

Takeda Site 48

Phoenix, Arizona, 85054, United States

Location

Takeda Site 39

Redwood City, California, 94063, United States

Location

Takeda Site 31

Santa Ana, California, 92705, United States

Location

Takeda Site 18

Upland, California, 91786, United States

Location

Takeda Site 4

Orlando, Florida, 32803, United States

Location

Takeda Site 3

Atlanta, Georgia, 30328, United States

Location

Takeda Site 45

Boston, Massachusetts, 02115, United States

Location

Takeda Site 5

St Louis, Missouri, 63123, United States

Location

Takeda Site 2

Denver, North Carolina, 28037, United States

Location

Takeda Site 6

Cincinnati, Ohio, 45227, United States

Location

Takeda Site 42

Cleveland, Ohio, 44195, United States

Location

Takeda Site 49

Danville, Pennsylvania, 17821, United States

Location

Takeda Site 1

Columbia, South Carolina, 29201, United States

Location

Takeda Site 44

Dallas, Texas, 75231, United States

Location

Takeda Site 10

Norfolk, Virginia, 23510, United States

Location

Takeda Site 21

Ottawa, Ontario, K2A 3Z3, Canada

Location

Takeda Site 11

Toronto, Ontario, M5S 3A3, Canada

Location

Takeda Site 50

Montreal, Quebec, H4J 1C5, Canada

Location

Takeda Site 25

Montpellier, Herault, 34090, France

Location

Takeda Site 43

Toulouse, Midi-Pyrenees, 31059, France

Location

Takeda Site 40

Lyon, 69004, France

Location

Takeda Site 29

Paris, 75013, France

Location

Takeda Site 47

Regensberg, Bavaria, 93053, Germany

Location

Takeda Site 34

Berlin, 10117, Germany

Location

Takeda Site 26

Schwerin, 19053, Germany

Location

Takeda Site 32

Rome, Lazio, OO133, Italy

Location

Takeda Site 30

Bologna, 40139, Italy

Location

Takeda Site 16

Kurume-shi, Fukuka-Ken, 830-0011, Japan

Location

Takeda Site 13

Kitakyushu-shi, Fukuoka, 802-0084, Japan

Location

Takeda Site 14

Fukuoka, Fukuoka-Shi Hakata-Ku, 812-0025, Japan

Location

Takeda Site 9

Kohoku, Kanagawa, 222-0033, Japan

Location

Takeda Site 7

Kumamoto, Kumamoto, 861-0954, Japan

Location

Takeda Site 17

Isahaya-shi, Nagasaki, 854-0081, Japan

Location

Takeda Site 15

Urasoe-Shi, Okinawa, 901-2132, Japan

Location

Takeda Site 12

Yodogawa, Osaka, 532-0003, Japan

Location

Takeda Site 8

Bunkyo-ku, Tokyo, 112-0012, Japan

Location

Takeda Site 19

Kodaira-shi, Tokyo, 187-8551, Japan

Location

Takeda Site 20

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Takeda Site 28

Zwolle, Netherlands

Location

Takeda Site 27

Bergen, Hordaland, 5021, Norway

Location

Takeda Site 33

Oslo, 450, Norway

Location

Takeda Site 37

Vitoria-Gasteiz, Alava, 1004, Spain

Location

Takeda Site 38

Castellon, Castellon, 12004, Spain

Location

Takeda Site 35

Barcelona, 8035, Spain

Location

Takeda Site 36

Barcelona, O8036, Spain

Location

Takeda Site 24

Madrid, 28046, Spain

Location

Takeda Site 41

Valencia, 46600, Spain

Location

Takeda Site 22

Barmelweid, Canton of Aargau, 5017, Switzerland

Location

Takeda Site 23

Bern, 3010, Switzerland

Location

Takeda Site 51

Lugano, CH-6900, Switzerland

Location

Takeda Site 46

Cambridge, CB2 OAY, United Kingdom

Location

Takeda Site 52

London, SE1 9RT, United Kingdom

Location

Takeda Site 53

London, W1G 9ST, United Kingdom

Location

Related Links

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 2, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

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

DE (3); NO (2); ES (6); JP (11); CA (3); FR (4); US (15); IT (2); NL (1); CH (3); GB (3)