4 completed, 2 withdrawn, 1 terminated. 3 Early Phase 1, 2 Phase 3, 1 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Early Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 2 | Completed 1, Withdrawn 1 |
| Phase 1 | 1 | Withdrawn 1 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder LYN-005 (risperidone), Placebo for LYN-005, IR Risperidone - Schizophrenia, Schizoaffective Disorder | Phase 3 | Withdrawn | Lyndra Inc. | 2025-04-18 | 2025-04-08 | |
| Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005 LYN-005, Risperidone - Schizophrenia, Schizoaffective Disorder | Phase 3 | Completed | Lyndra Inc. | 83 | 2023-04-13 | 2024-10-24 |
| Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy Levomethadone HCl, Methadone, Morphine Sulfate - Opioid Use Disorder, Moderate | Phase 1 | Withdrawn | Lyndra Inc. | 2022-02-28 | 2023-01-19 | |
| A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules LYN-005 - Schizophrenia Schizoaffective | Phase 2 | Completed | Lyndra Inc. | 34 | 2020-08-13 | 2023-02-08 |
| Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules Containing Memantine Hydrochloride in Healthy Adults LYN-057, Imaging Assessment (MRI), Imaging Assessment (U/S) - Alzheimer Disease, Gastric Retention | Early Phase 1 | Completed | Lyndra Inc. | 8 | 2018-09-10 | 2019-02-26 |
| Study to Evaluate Safety/Duration in Stomach of Extended Release Capsules in Healthy Adults Formulation A, Formulation B, Formulation C - Gastric Retention, Healthy | Early Phase 1 | Completed | Lyndra Inc. | 40 | 2018-06-25 | 2019-02-26 |
| Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects Memantine Hydrochloride MR Prototype Capsule Formulation A, Memantine Hydrochloride MR Prototype Capsule Formulation B, Memantine Hydrochloride MR Prototype Capsule Formulation C - Gastric Retention, Healthy | Early Phase 1 | Terminated | Lyndra Inc. | 3 | 2017-07-26 | 2019-06-05 |
Psychotic Disorders (3) · Schizophrenia (2) · Alzheimer Disease (1) · Lymphoma, Follicular (1) · Opioid-Related Disorders (1)
Magnetic Resonance Spectroscopy (3) · Risperidone (3) · Blood Specimen Collection (1) · D-Worm (1) · Endoscopy (1) · Granuflex E (1) · Hematologic Tests (1) · Memantine (1) · Methadone (1) · Morphine (1) · Radiography, Abdominal (1) · X-Rays (1)
Australia (2) · United States (2) · United Kingdom (1)
Richard Scranton, MD, MPH (3) · Sepehr Shakib, MD (2) · Nayana Nagaraj (1) · Stuart Mair, MBChB, DRCOG (1)
2017 (1), 4UH3DA050310-02 (1)