Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-30 @ 3:38 PM
Study NCT ID:
NCT06768658
Status:
TERMINATED
Last Update Posted:
2025-07-02
First Post:
2025-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS)
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Repeated Crossover Study to Evaluate the Safety and Tolerability of Intermittent Single Doses of TAK-951 in the Abortive Treatment of Subjects With Cyclic Vomiting Syndrome
Status:
TERMINATED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to business reasons prior to first subject dosed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study of TAK-951 in participants with cyclic vomiting syndrome (CVS).
The main aims of this study are as follows:
* To check for side effects from treatment with TAK-951.
* To learn how much TAK-951 participants can receive without getting side effects from it.
* To check how much TAK-951 stays in the blood over time to work out the best dose.
* The dose of TAK-951 will be checked to see how much stays in their blood over time.
* To see if it is possible to give treatment at home. Participants will be given TAK-951 injected just under the skin (subcutaneous or SC).
The main aims of this study are as follows:
* To check for side effects from treatment with TAK-951.
* To learn how much TAK-951 participants can receive without getting side effects from it.
* To check how much TAK-951 stays in the blood over time to work out the best dose.
* The dose of TAK-951 will be checked to see how much stays in their blood over time.
* To see if it is possible to give treatment at home. Participants will be given TAK-951 injected just under the skin (subcutaneous or SC).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: