Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT02477020
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, 6-Week Study to Evaluate the Efficacy and Safety of TAK-063 in Subjects With an Acute Exacerbation of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-09
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 purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063 compared with placebo in treatment of acutely exacerbated schizophrenia.
Detailed Description:
The drug being tested in this study is called TAK-063. TAK-063 is being tested to treat people who have schizophrenia. This study will look at the different symptoms associated with schizophrenia including cognitive symptoms, personal and social functioning and functional capacity (ability to perform tasks associated with real, everyday life such as household chores, communication, finance, transportation, and planning recreational activities) in people who take TAK-063.
The study enrolled 164 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* TAK-063 20 mg
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take the tablets once daily at nighttime. All participants will initially receive TAK-063, 20 mg/day. The dose may be titrated down to 10 mg/day, if intolerable.
The multi-center trial will be conducted in the United States. The overall time to participate in this study is 6 weeks. Participants will be hospitalized until the Week 3 visit. Participants will make 11 visits to the clinic during the treatment and 1 visit during the follow-up.
The study enrolled 164 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* TAK-063 20 mg
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take the tablets once daily at nighttime. All participants will initially receive TAK-063, 20 mg/day. The dose may be titrated down to 10 mg/day, if intolerable.
The multi-center trial will be conducted in the United States. The overall time to participate in this study is 6 weeks. Participants will be hospitalized until the Week 3 visit. Participants will make 11 visits to the clinic during the treatment and 1 visit during the follow-up.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1169-6472 | REGISTRY | WHO | View |