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 range18 Years – 65 Years
SexALL
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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.
✓. 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.
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
. 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.