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Trial record 74 of 146 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 28, 2019
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

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 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 4-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 duration of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening.

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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
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


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) [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline compared to double-blind treatment period 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 30 days post-final dose ]
    To assess adverse events as a criteria of safety and tolerability


Secondary Outcome Measures :
  1. To evaluate the 50% XEN1101 response rates in comparison to placebo [ 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 treatment period

  2. To evaluate trends in focal seizure frequency over time in the treatment period [ Time Frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56) ]
    Median absolute, change and percent change from baseline in weekly focal seizure frequency for each week of the double-blind treatment period



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 <35 kg/m2
  • Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
  • 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 study
  • Must be willing to comply with the contraception requirements
  • 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
  • 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 ≥49 days and acceptable hematology and LFT values (or discontinued felbamate 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
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Strada Patient Care Center Recruiting
Mobile, Alabama, United States, 36604
United States, Arizona
Xenoscience, Inc. Recruiting
Phoenix, Arizona, United States, 85004
Contact: Lauren Batorski    602-265-6500      
United States, Arkansas
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program Recruiting
San Francisco, California, United States, 94109
Neurological Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Jaime Latorre    310-315-1456      
United States, Florida
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
Harbor Professional Center Recruiting
Port Charlotte, Florida, United States, 33952
Contact: Maria Vasconcelos    941-623-9744      
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Advent Health Tampa Pepin Heart Institute Recruiting
Tampa, Florida, United States, 33613
Contact    813-610-8110      
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, Kentucky
Bluegrass Epilepsy Research Recruiting
Lexington, Kentucky, United States, 40504
Contact    859-313-4989      
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      
United States, Missouri
Max Benzaquen, M.D., PC Recruiting
Chesterfield, Missouri, United States, 63017
United States, New Jersey
Northeast Regional Epilepsy Group Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Victoria Sica    201-343-6676      
United States, New York
Dent Neurosciences Research Center Recruiting
Amherst, New York, United States, 14226
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
University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43606
Contact: Andrea Korsnack    419-383-3801      
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      
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
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
United States, Washington
MultiCare Rockwood Neurology Center Recruiting
Spokane, Washington, United States, 99204
Contact: Abby Crooks    509-342-3048      
United States, West Virginia
CAMC Neurology Recruiting
Charleston, West Virginia, United States, 25301
Canada, Ontario
University Health Network-Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Spain
Centro de Neurologia Avanzada Recruiting
Sevilla, Andalusia, Spain, 41013
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 Vithas La Salud Recruiting
Granada, Spain, 18008
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
United Kingdom
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 28, 2019
Last Verified: August 2019

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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