A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules
Completed · Phase 2 · Has a placebo group
Conditions studied: Schizophrenia Schizoaffective
In brief
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.
Key facts
- Study ID
- NCT04567524
- Run by
- Lyndra Inc.
- People needed
- 34
- Starts
- 2020-08-13
- Expected to finish
- 2020-12-22
- Last updated by the study team
- 2023-02-08
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Collaborative Neuroscience Research, LLC — Long Beach, California, United States
- Atlanta Center for Medical Research — Atlanta, Georgia, United States
- Hassman Research Institute — Marlton, New Jersey, United States
- Community Clinical Research, Inc — Austin, Texas, United States
- Pillar Clinical Research, LLC — Richardson, Texas, United States
Full record on ClinicalTrials.gov
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