A Study of TAK-994 in Adults With Narcolepsy

  • STATUS
    Recruiting
  • End date
    Jan 30, 2022
  • participants needed
    112
  • sponsor
    Takeda
Updated on 22 September 2021
Investigator
Takeda Study Registration Call Center
Primary Contact
Nihon University Itabashi Hospital Dept of Neuropsychiatry (7.2 mi away) Contact
+151 other location

Summary

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 include TAK-994 in it. Participants will take TAK-994 or placebo for 2 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.

Description

The drug being tested in the study is called TAK-994. TAK-994, is being tested to treat participants with NT1. Participants who completed Part B of TAK-994-1501(NCT04096560) will be invited to participate in this study.

This study will enroll approximately 112 patients to receive one of three different TAK 994 doses for 8 weeks in Period 1 (Dose-blind Active Drug Extension Period). Participants will be randomly assigned to one of these different TAK 994 doses which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

Following Period 1, participants will continue into Period 2 (Double-blind Randomized Withdrawal Period) and will receive the same doses of TAK-994 or placebo for 2 weeks. Following Period 2, participants will enter Period 3 (Open-label Extension Period) and will receive dose 2 of TAK-994 for the first two weeks. This dose can be adjusted up to dose 3 based on non-response or down to dose 1 based on the safety for the first 4 weeks. For the following 6 weeks, doses may only be adjusted downwards (either back to dose 2 for those who went up to dose 3 or down to dose 1) due to safety. Period 3 will last a total of 10 weeks.

This multi-center trial will be conducted worldwide. The duration of treatment in this study is 20 weeks plus a 2-week safety follow up period. Participants will visit the clinic 12 times after the first dosing.

Details
Condition Narcolepsy Type 1
Treatment Placebo, TAK-994
Clinical Study IdentifierNCT04820842
SponsorTakeda
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

A participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 (NCT04096560) Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled
The participant must have blood pressure (BP) <140 mm Hg (systolic) and <90 mm Hg (diastolic) at the final collection point in TAK-994-1501 (Baseline 1). The participant may have a history of hypertension and be on antihypertensive medication treatment as long as the BP meets these criteria. BP measurements should be obtained after the participant has been resting for a minimum of 10 minutes and will be repeated 3 times. The mean BP (of the last 2 assessments) obtained will be used for assessing participant eligibility

Exclusion Criteria

The participant has a clinically significant severe ongoing AE related to the study drug from the prior study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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