CLINICAL TRIALS PROFILE FOR XEN1101

Clinical Trials for XEN1101

Trial ID	Title	Status	Sponsor	Phase	Summary
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).
NCT04827901 ↗	XEN1101 for Major Depressive Disorder	Recruiting	James Murrough	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).

Clinical Trial Conditions for XEN1101

Condition Name

Condition Name for
Intervention	Trials
Focal Epilepsy	2
Focal Onset Seizures	2
Healthy Volunteers	2
Major Depressive Disorder	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Seizures	4
Epilepsies, Partial	2
Disease	2
Depressive Disorder, Major	2

Clinical Trial Locations for XEN1101

Trials by Country

Trials by Country for
Location	Trials
United States	30
United Kingdom	6
Spain	4
Canada	2
Italy	1

Trials by US State

Trials by US State for
Location	Trials
Texas	2
California	2
New York	2
Massachusetts	1
Colorado	1

Clinical Trial Progress for XEN1101

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	3
Phase 1	3

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for XEN1101

Sponsor Name

Sponsor Name for
Sponsor	Trials
Xenon Pharmaceuticals Inc.	9
Worldwide Clinical Trials	4
NCGS, Inc.	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	10
Other	6
NIH	1