Ignite Creation Date:
2024-05-06 @ 4:04 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02446132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2015-05-11
Brief Title:
Long Term Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimers Type
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Phase 3 Multicenter Long Term Extension Study of the Safety and Efficacy of AVP-786 Deuterated d6 Dextromethorphan Hydrobromide d6-DMQuinidine Sulfate Q for the Treatment of Agitation in Patients With Dementia of the Alzheimers Type
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
This is an extension study of the Phase 3 Studies 15-AVP-786-301 15-AVP-786-302 and 17-AVP-786-305 which also allows participants from the Phase 2 Study 12-AVR-131 to be included
Detailed Description:
Participant has successfully completed Studies 15-AVP-786-301 15-AVP-786-302 12-AVR-131 or 17-AVP-786-305
Participants will be enrolled in the study for approximately 56 weeks participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks
Approximately 1200 participants will be enrolled at approximately 250 centers globally
All participants enrolled will receive AVP-786 the treatment dose assigned will be masked to the participant investigator study staff and the sponsor
Participants will be enrolled in the study for approximately 56 weeks participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks
Approximately 1200 participants will be enrolled at approximately 250 centers globally
All participants enrolled will receive AVP-786 the treatment dose assigned will be masked to the participant investigator study staff and the sponsor
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 |
|---|---|---|---|
| 2017-002455-29 | EUDRACT_NUMBER | None | None |