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Trial record 74 of 147 for:    epilepsy AND Bethesda

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796962
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : August 20, 2020
Sponsor:
Collaborator:
NCGS, Inc.
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Focal Epilepsy Drug: XEN1101 Phase 2

Detailed Description:
The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 6-week post treatment follow-up period. In order to be included in the study, patients must already be treated with a stable dose of 1 to 3 allowable current anti-epileptic drugs for at least one month prior to screening, during baseline, and throughout the double-blind portion (DBP) of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening. A one year OLE will be available to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of XEN1101 during this extension period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: 25 mg XEN1101
Capsule filled with 25 mg XEN1101
Drug: XEN1101
Oral dose

Experimental: 20 mg XEN1101
Capsule filled with 20 mg XEN1101
Drug: XEN1101
Oral dose

Experimental: 10 mg XEN1101
Capsule filled with 10 mg XEN1101
Drug: XEN1101
Oral dose

Placebo Comparator: Placebo
Placebo capsule
Drug: XEN1101
Oral dose




Primary Outcome Measures :
  1. To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency (e.g., median percent change in focal seizure frequency) in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind treatment period (DBP) [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo

  2. To assess the safety and tolerability of XEN1101 (e.g., adverse events) in adults with focal epilepsy taking 1-3 AEDs [ Time Frame: From screening (up to 28 days prior to baseline) through to 42 days post-final dose ]
    To assess adverse events as criteria for safety and tolerability


Secondary Outcome Measures :
  1. To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP

  2. To evaluate trends in focal seizure frequency over time in the DBP [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Percent change from baseline in weekly focal seizure frequency for each week in the DBP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
  • BMI ≤40 kg/m2
  • Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
  • Prior neuroimaging within the last 10 years and documentation is available
  • Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
  • Must be willing to comply with the contraception requirements
  • Males must agree not to donate sperm from the time of the first administration of study drug until 6 months after the last dose. Females must agree not to donate ova from the time of the first administration of study drug until 6 months after the last dose.
  • Able to keep accurate seizure diaries

Key Exclusion Criteria:

  • History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only
  • Presence or previous history of Lennox-Gastaut syndrome
  • Seizures secondary to other diseases or conditions
  • History of repetitive seizures within the last 12 months where the individual seizures cannot be counted
  • History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment
  • Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt
  • History or presence of any significant medical or surgical condition or uncontrolled medical illness at screening, or history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma
  • Any clinically significant abnormalities on pre-study physical examination, vital signs, laboratory values or ECG indicating a medical problem that would preclude study participation including but not limited to:

    1. History of presence of long QT syndrome; QTcF > 450 msec at baseline; family history of sudden death of unknown cause
    2. History of skin or retinal pigment epithelium abnormalities caused by ezogabine
  • Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)
  • If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for 2 months (or no less than 49 days) and acceptable hematology and LFT history and values prior to Screening. If received in the past, felbamate must have been discontinued 2 months (or no less than 49 days) prior to Screening.
  • Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
  • Current use of a ketogenic diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796962


Contacts
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Contact: NCGS, Inc. 1 844 541 4482 clinicaltrials@ncgs.com
Contact: Xenon Pharmaceuticals Inc. 1 604 484 3300 clinicaltrials@xenon-pharma.com

Locations
Hide Hide 82 study locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Katlyn Jackson    205-934-1654      
Strada Patient Care Center Recruiting
Mobile, Alabama, United States, 36604
Contact    215-445-8290      
United States, Arizona
Xenoscience, Inc. Recruiting
Phoenix, Arizona, United States, 85004
Contact: Lauren Batorski    602-265-6500      
Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
United States, Arkansas
Clinical Trials, Inc. Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Altman Clinical Translational Research Institute (ACTRI) Recruiting
La Jolla, California, United States, 92037
Contact: Hannah Kim    858-249-0867      
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program Recruiting
San Francisco, California, United States, 94109
Contact: Anna von Sica    415-600-1107      
United States, Colorado
University of Colorado Hospital Anschutz Outpatient Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact    720-848-8583      
United States, Florida
University of Florida Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Visionary Investigators Network Recruiting
Miami, Florida, United States, 33133
Don Clinical Research Center Recruiting
Miami, Florida, United States, 33136
The Neurology Research Group, LLC. Recruiting
Miami, Florida, United States, 33176
Research Institute of Orlando, LLC Recruiting
Orlando, Florida, United States, 32806
Medsol Clinical Research Center Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Maria Vasconcelos    941-623-9744      
University of South Florida Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Emory Brain Health Center Recruiting
Atlanta, Georgia, United States, 30329
United States, Hawaii
Hawaii Pacific Neuroscience Recruiting
Honolulu, Hawaii, United States, 96817
Contact    808-564-6141      
United States, Idaho
Consultants in Epilepsy and Neurology, PLLC Recruiting
Boise, Idaho, United States, 83702
United States, Illinois
Northwestern Medical Group, Department of Neurology Recruiting
Chicago, Illinois, United States, 60611
Contact    312-926-1672      
United States, Kentucky
Bluegrass Epilepsy Research Recruiting
Lexington, Kentucky, United States, 40504
Contact    859-313-4989      
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Partners Neurology Recruiting
Scarborough, Maine, United States, 04074
United States, Maryland
Mid-Atlantic Epilepsy and Sleep Center Recruiting
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Boston Neuro Research Center Recruiting
South Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Minneapolis Clinic of Neurology, Ltd. Recruiting
Golden Valley, Minnesota, United States, 55422
Contact: Joanne Rogin, PhD    763-302-4162      
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Minnesota Epilepsy Group, P. A. Recruiting
Saint Paul, Minnesota, United States, 55102
United States, Nevada
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact    775-982-7478      
United States, New Jersey
JFK Neuroscience Institute, JFK Medical Center Recruiting
Edison, New Jersey, United States, 08820
Northeast Regional Epilepsy Group Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Victoria Sica    201-343-6676      
Institute of Neurology and Neurosurgery at Saint Barnabas Recruiting
Livingston, New Jersey, United States, 07039
Contact: Munazza Malik, MD    973-322-7425      
Northeast Regional Epilepsy Group Recruiting
Morristown, New Jersey, United States, 07960
United States, New York
Dent Neurosciences Research Center Recruiting
Amherst, New York, United States, 14226
NYU Langone Medical Center/NYU School of Medicine Recruiting
New York, New York, United States, 10016
Northwell Health - Lenox Hill Recruiting
New York, New York, United States, 10075
SUNY Upstate Medical University Institute for Human Performance Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville Neurology Specialists, PA Recruiting
Asheville, North Carolina, United States, 28806
Contact    828-210-9311      
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
UC Gardner Neuroscience Institute Recruiting
Cincinnati, Ohio, United States, 45219
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43606
Contact: Andrea Korsnack    419-383-3801      
UC Health Physicians Office North Recruiting
West Chester, Ohio, United States, 45069
United States, Oregon
Providence Neurological Specialties East Recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Thomas Jefferson University Comprehensive Epilepsy Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Lewis Katz School of Medicine at Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Mercedes Jacobson    215-707-3040      
Allegheny Neurological Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact    843-792-1115      
United States, Tennessee
Vanderbilt Epilepsy Clinic Recruiting
Nashville, Tennessee, United States, 37232
Contact    615-875-2532      
United States, Texas
Austin Epilepsy Care Center Recruiting
Austin, Texas, United States, 78758
Contact: Celeste Gonzalez    512-339-8831      
James W. Aston Ambulatory Care Center Recruiting
Dallas, Texas, United States, 75390
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Floyd Jones    210-567-8222      
United States, Utah
University of Utah Health Clinical Neurosciences Center Recruiting
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Carilion Neurology Clinic Recruiting
Roanoke, Virginia, United States, 24016
United States, Washington
University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Canada, British Columbia
Children's and Women's Health Centre of British Columbia (BC Children's Hospital) Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5A5
University Health Network-Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Spain
Hospital Virgen Macarena Recruiting
Sevilla, Andalusia, Spain, 41009
Centro de Neurologia Avanzada Recruiting
Sevilla, Andalusia, Spain, 41013
Hospital Germans Trias I Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Hospital Clinico Universitario de Santiago Recruiting
Santiago de Compostela, Galicia, Spain, 15706
Clínica Universidad Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital de la Santa Cren i Saut Pau Recruiting
Barcelona, Spain, 08041
Hospital Vithas La Salud Recruiting
Granada, Spain, 18008
Hospital Ruber Internacional Recruiting
Madrid, Spain, 28036
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Regional Universitario de Málaga Recruiting
Málaga, Spain, 29010
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain, 46026
Hospital Clínico Universitario Valladolid Recruiting
Valladolid, Spain, 47003
United Kingdom
Royal Victoria Infirmary Recruiting
Newcastle Under Lyme, England, United Kingdom, NE1 4LP
The Walton Centre NHS FT Recruiting
Liverpool, North West England, United Kingdom, L97LJ
Ninewells Hospital and Medical School Tayside NHS Board Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Institute of Neurological Sciences Recruiting
Glasgow, Scotland, United Kingdom, G514TF
University Hospital of Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
St. George's University Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Xenon Pharmaceuticals Inc.
NCGS, Inc.
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Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03796962    
Other Study ID Numbers: XPF-008-201
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xenon Pharmaceuticals Inc.:
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases