A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Part… (NCT06878833) | Clinical Trial Compass
WithdrawnPhase 3
A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
Stopped: Sponsor stopped operations
0Started 2025-04-18
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged ≥18 and ≤65 years.
. Current diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria as confirmed by the Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2).
. Psychiatric criteria:
. Duration of diagnosis of schizophrenia or schizoaffective disorder for ≥2 years.
. Outpatient; not hospitalized for worsening of schizophrenia within the last 6 months (partial hospitalization for social management within this time period is acceptable).
. Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: OL Cohort: Screening through Day 57; DB Cohort: Screening through Day 203
. Stabilized on a therapeutic dose of an oral antipsychotic drug for a minimum of 6 weeks at the time of Screening.
. On a stable dosage of all permitted non-antipsychotic medications (except for medication to be used on an as-needed basis) for at least 1 month before the Screening visit and for the duration of the study.
Exclusion criteria
. Participants with known clinically significant esophageal or GI disease, including but not limited to:
. Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or participants with high risk of stricture, e.g., Crohn's disease.
. Prior varices or small or large bowel obstructions.
. Prior abdominal or upper gastrointestinal surgery including gastric bypass or removal of a significant portion of the gastrointestinal (GI) tract that may impose a high risk of strictures (prior uncomplicated laparoscopic procedures including appendectomy or colectomy are permitted).
. History of diarrhea or constipation within 3 months of Screening that in the opinion of the investigator would be considered clinically significant.
. Multiple episodes of moderate or severe abdominal pain within 3 months of Screening.
. History of moderate to severe Acid Reflux Disease or a score of ≥2 on the Acid Reflux Severity Scale (ARSS) \[2\], indicating moderate to severe symptoms.