Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470828
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
A Study of TAK-861 for the Treatment of Narcolepsy Type 1
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy Narcolepsy Type 1
Status:
RECRUITING
Status Verified Date:
2024-10
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 of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day called excessive daytime sleepiness or EDS after 3 months of treatment Other aims are to learn how effective TAK-861 is in lowering the number of sudden unexpected attacks of muscle weakness while staying conscious cataplexy in a week to learn the effect TAK-861 has on participants ability to maintain attention participants overall quality of life the spectrum of narcolepsy symptoms and daily life functions and to learn about the safety of TAK-861
Detailed Description:
The drug being tested in this study is called TAK-861 TAK-861 is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 NT1
The study will enroll approximately 152 patients Participants will be randomly assigned by chance like flipping a coin to one of the three treatment groups
1 TAK-861 Dose 1
2 TAK-861 Dose 2
3 Placebo
The study drug will be administered for 12 weeks This multi-center trial will be conducted globally
The study will enroll approximately 152 patients Participants will be randomly assigned by chance like flipping a coin to one of the three treatment groups
1 TAK-861 Dose 1
2 TAK-861 Dose 2
3 Placebo
The study drug will be administered for 12 weeks This multi-center trial will be conducted globally
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU CTIS | OTHER | None | None |