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

Takeda

Status and phase: Active, not recruiting; Phase 3

Conditions: Narcolepsy Type 1

Treatments: Drug: TAK-861; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06470828

TAK-861-3001

jRCT2051240083 (Registry Identifier)

2023-508465-32-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full description

The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (NT1).

The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups:

1. TAK-861 Dose 1
2. TAK-861 Dose 2
3. Placebo

The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.

Enrollment: 168 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m^2).
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.
3. The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
4. 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].

Exclusion criteria

1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
2. 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).
3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
4. The participant has a history of cancer in the past 5 years.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has a history of epilepsy, seizure, or convulsion.
7. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 3 patient groups, including a placebo group

TAK-861 Dose 1

Experimental group

Description:

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

Treatment:

Drug: TAK-861

TAK-861 Dose 2

Experimental group

Description:

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

Treatment:

Drug: TAK-861

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo