Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT06878833
Status:
WITHDRAWN
Last Update Posted:
2025-04-08
First Post:
2025-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
Sponsor:
Lyndra Inc.
Organization:
Study Overview
Official Title:
A Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
Status:
WITHDRAWN
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor stopped operations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Starlyng-2
Brief Summary:
Lyndra Therapeutics, Inc., is developing a long-acting oral (LAO) treatment of risperidone (LYN-005) in a capsule dosage form (LYNX® drug delivery platform). The intent of LYN-005 is to reduce the dosing frequency of orally-administered risperidone to once weekly or less and, thereby improve treatment adherence and management of schizophrenia and schizoaffective disorder.
This study will evaluate the safety and tolerability of multiple administrations of LYN-005 at 3 dose levels.
This study will evaluate the safety and tolerability of multiple administrations of LYN-005 at 3 dose levels.
Detailed Description:
None
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?: