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A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

NCT07363720 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-08

No results posted yet for this study

Summary

The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.

Conditions

  • Narcolepsy Type 1 (NT1)
  • Narcolepsy With Cataplexy

Interventions

DRUG

TAK-861

TAK-861 tablets

DRUG

Placebo

TAK-861-matching placebo tablets

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
2026-01-29
Primary Completion
2026-10-02
Completion
2026-10-02
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT07363720 on ClinicalTrials.gov