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

NCT05687916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-01-09

Study results available
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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

Interventions

DRUG

Placebo

TAK-861 placebo matching tablets.

DRUG

TAK-861 2 mg

TAK-861 2 mg tablets.

DRUG

TAK-861 2 mg and 5 mg

TAK-861 2 mg and 5 mg tablets.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2023-12-13
Completion
2023-12-25
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687916 on ClinicalTrials.gov