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A Study of TAK-861 in Participants With Narcolepsy Type 1

NCT05687903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-01-09

Study results available
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Summary

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific.

The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

Conditions

Interventions

DRUG

TAK-861

TAK-861 oral tablets

DRUG

Placebo

Placebo oral tablets matching TAK-861

Sponsors & Collaborators

Principal Investigators

  • Study 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
2023-12-14
Completion
2023-12-14
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT05687903 on ClinicalTrials.gov