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A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder

NCT06878833 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LYN-005 (risperidone)

long-acting oral (LAO) capsule

DRUG

Placebo for LYN-005

capsule

DRUG

IR Risperidone

tablets

DRUG

Placebo for IR Risperidone

tablets

Sponsors & Collaborators

  • Lyndra Inc.

    lead INDUSTRY

Principal Investigators

  • Nayana Nagaraj · Lyndra Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06878833 on ClinicalTrials.gov