Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05687916
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2023-01-09
Brief Title:
A Study of TAK-861 in Participants With Narcolepsy Type 2
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy Narcolepsy Type 2
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy including excessive daytime sleepiness EDS as measured by sleep latency from the Maintenance of Wakefulness Test MWT
The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups 20 per group to take one of two different doses of TAK-861 or a placebo All the participants will receive the treatment for 8 weeks Participants will be asked to complete some questionnaires during the study This trial will be conducted in North America Europe and Asia Pacific
The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups 20 per group to take one of two different doses of TAK-861 or a placebo All the participants will receive the treatment for 8 weeks Participants will be asked to complete some questionnaires during the study This trial will be conducted in North America Europe and Asia Pacific
Detailed Description:
The drug being tested in this study is called TAK-861 TAK-861 is being tested to treat people who have narcolepsy without cataplexy Narcolepsy Type 2 NT2 This study will evaluate the efficacy safety and tolerability of 2 oral doses of TAK-861
The study will enroll approximately 60 patients Participants will be randomly assigned by chance like flipping a coin to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
TAK-861 Dose 1
TAK-861 Dose 2
Placebo dummy inactive pill - this is a tablet that looks like the study drug but has no active ingredient
This is a multi-center trial to be conducted worldwide The overall time to participate in this study is approximately 18 weeks
The study will enroll approximately 60 patients Participants will be randomly assigned by chance like flipping a coin to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
TAK-861 Dose 1
TAK-861 Dose 2
Placebo dummy inactive pill - this is a tablet that looks like the study drug but has no active ingredient
This is a multi-center trial to be conducted worldwide The overall time to participate in this study is approximately 18 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002966-34 | EUDRACT_NUMBER | None | None |
| U1111-1277-4261 | OTHER | None | None |
| jRCT2031230050 | REGISTRY | jRCT | None |