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A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy

NCT04096560 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-10-29

Study results available
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Summary

The main aims of the study are:

* To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.
* To check what dose range provides adequate relief of narcolepsy symptoms.
* To check how much TAK-994 stays in the blood of participants, over time.

The study will have 4 parts. Participants can only join 1 of the parts.

A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it.

B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days.

C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days.

D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

Conditions

  • Narcolepsy Type 1 (NT1)
  • Narcolepsy Type 2 (NT2)

Interventions

DRUG

TAK-994

TAK-994 tablets.

DRUG

Placebo

TAK-994 placebo-matching tablets.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2021-11-05
Completion
2021-11-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Czechia
  • Finland
  • France
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain

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 NCT04096560 on ClinicalTrials.gov