CLINICAL TRIALS PROFILE FOR XEN1101
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Clinical Trials for XEN1101
Trial ID | Title | Status | Sponsor | Phase | Summary |
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NCT03340220 ↗ | Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN1101 | Unknown status | Xenon Pharmaceuticals Inc. | Phase 1 | The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK data, the clinical trial has been designed to include a pharmacodynamic read-out by incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts. |
NCT03468725 ↗ | Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Doses of XEN1101 | Completed | Xenon Pharmaceuticals Inc. | Phase 1 | The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study. |
NCT03796962 ↗ | A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy | Active, not recruiting | NCGS, Inc. | Phase 2 | The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE). |
NCT03796962 ↗ | A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy | Active, not recruiting | Xenon Pharmaceuticals Inc. | Phase 2 | The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE). |
NCT04827901 ↗ | XEN1101 for Major Depressive Disorder | Recruiting | Baylor College of Medicine | Phase 2 | This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals). |
NCT04827901 ↗ | XEN1101 for Major Depressive Disorder | Recruiting | National Institute of Mental Health (NIMH) | Phase 2 | This project is designed to examine the neuronal KCNQ2/3 potassium (K+) channel subtype as a novel treatment target for mood disorders through the administration of the KCNQ-selective channel opener XEN1101 (Xenon Pharmaceuticals). |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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