Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01813019
Status:
TERMINATED
Last Update Posted:
2017-01-02
First Post:
2013-03-14
Brief Title:
Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder OCD Patients Resistant to Selective Serotonin Reuptake Inhibitor SSRI Therapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Proof of Concept Study to Evaluate the Effect of AFQ056 in Obsessive Compulsive Disorder OCD Patients Resistant to Selective Serotonin Reuptake Inhibitor SSRI Therapy
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was prematurely terminated at the time of the first Interim Analysis IA as the study did not meet its primary efficacy objective
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 determine whether AFQ056 as an add on therapy to SSRIs can have beneficial effects by reducing the total score of Y-BOCS Yale and Brown Obsessive Compulsive Scale in OCD patients resistant to SSRI treatment failed SSRI over 12 weeks at appropriate doses
Detailed Description:
This was a randomized double-blind parallel group placebo-controlled 12-weeks 200 mg bid oral dose treatment of AFQ056 following a 4 week up-titration period and followed by a 3 week down-titration period or matched placebo in patients diagnosed with OCD and on background SSRI treatment for at least 12 weeks Study was prematurely terminated at the time of the first Interim Analysis IA as the study did not meet its primary efficacy objective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None