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A Study of TAK-994 in Adults With Narcolepsy

Sponsored by Takeda

About this trial

Last updated 2 years ago

Study ID

TAK-994-1504

Status

Terminated

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994. Participants will take one of 3 different TAK-994 dose for 8 weeks. Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks. Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo. The study doctors will check for side effects from TAK-994 and placebo throughout the study. Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

What are the participation requirements?

Yes

Inclusion Criteria

Both men and women can take part.
Must be an adult from 18 to 65 years old.
Must have Narcolepsy Type 1 and have completed Part B of the TAK-994-1501 study.
No

Exclusion Criteria

Cannot still have clinically important side effects from the study drug of the TAK-994-1501 study.

Additional entry criteria will be discussed with the study doctor.

Trial Results Summary

Locations

Location

Status

For more information, view the full study details:

NCT048208422021-000251-39jRCT2071210015