CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
LYN-005drug
Likely dose
LYN-005 28 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04567524
NCT04567524Phase 2Completed
CompareCT.gov

A Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Risperidone Extended Release Capsules in Subjects With Schizophrenia, Schizoaffective Disorder

Lyndra Inc.·interventional·Posted Sep 28, 2020·Updated Feb 8, 2023

In Brief

A Phase 2 clinical trial evaluating LYN-005 for Schizophrenia Schizoaffective. Completed, enrolled 34 participants across 5 sites.

Detailed Summary

Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005) presented in a capsule dosage form with the intent of reducing the frequency of dosing orally-administered medications to once weekly or less and thereby improving the management of schizophrenia. Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to IR risperidone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia Schizoaffective
CountriesUnited States
CollaboratorsWorldwide Clinical Trials

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 28, 2020
Enrollment StartAug 13, 2020
Primary CompletionDec 22, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.8 years ago

Interventions

LYN-005drug

LYN-005 (14 or 28 mg weekly) plus IR risperidone matched placebo.