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A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

NCT03796962 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2024-09-24

Study results available
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Summary

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).

Conditions

  • Focal Epilepsy

Interventions

DRUG

XEN1101

Oral dose

Sponsors & Collaborators

Principal Investigators

  • Study Director · Xenon Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2021-09-02
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Georgia
  • Germany
  • Italy
  • Moldova
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03796962 on ClinicalTrials.gov