Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02534038
Status:
TERMINATED
Last Update Posted:
2020-10-26
First Post:
2015-08-11
Brief Title:
Safety Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Sponsor:
Avanir Pharmaceuticals
Organization:
Avanir Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Study to Assess the Safety Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition in Patients With Neurodegenerative Disorders
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated prematurely because of difficulty with recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder
Detailed Description:
Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment
This is a multicenter randomized double-blind placebo-controlled cross-over study consisting of two 6-week treatment periods
Approximately 12 participants will be enrolled at approximately 2 centers in the United States
Following screening procedures for assessment of inclusion and exclusion criteria eligible participants will be randomized into the study
This is a multicenter randomized double-blind placebo-controlled cross-over study consisting of two 6-week treatment periods
Approximately 12 participants will be enrolled at approximately 2 centers in the United States
Following screening procedures for assessment of inclusion and exclusion criteria eligible participants will be randomized into the study
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