A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

NCT03116828 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 093-701
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 55

Brief Summary

A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures

Conditions

Epilepsy With Partial On-set Seizures

Keywords

epilepsy; seizures; partial on-set seizures

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Completing 24 Weeks Adjunctive Therapy During Maintenance Phase

  Phase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with Partial-onset seizures (POS). Two groups of ESL-naïve subjects will be evaluated

  From the date of the first dose of the study drug until the completion of 24 weeks Maintenance Phase

Study Arms (2)

eslicarbazepine acetate (arm 1)

EXPERIMENTAL

eslicarbazepine acetate (as first add-on)mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)

Drug: Eslicarbazepine acetate

eslicarbazepine acetate (arm 2)

EXPERIMENTAL

eslicarbazepine acetate (as later add-on)

Drug: Eslicarbazepine acetate

Interventions

Eslicarbazepine Acetate DRUG

eslicarbazepine acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)

Also known as: Aptiom, ESL, SEP-0002093, BIA-2-093

eslicarbazepine acetate (arm 1); eslicarbazepine acetate (arm 2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 18 years of age.
• Subject is willing and able to sign informed consent.
• Subject has a documented diagnosis of epilepsy with simple POS with a motor component or complex POS with or without secondarily generalized seizures as defined in the Classification of Seizures of the International League Against Epilepsy
• Subject has a documented electroencephalogram within 10 years prior to screening.
• Subject has had at least 3 POS during previous six months.
• Subject has had a sufficient number of seizures at time of enrollment to justify adjunctive therapy, as determined by the Investigator.
• Subjects are required to be ESL-naïve AND
• Maintained on a stable LEV or LTG regimen for at least 1 month (28 days) prior to screening with no history of adjunctive treatment (for Arm 1, ESL as first add-on).
• Maintained on a stable dose of 1-2 AEDs (excluding OXC) for at least 1 month (28 days) prior to screening and who have had prior adjunctive treatment (for Arm 2, ESL as later add-on).
• If the subject is treated with any stimulation device for epilepsy Vagal Nerve Stimulation (VNS), Responsive Neurostimulator (RNS), or similar, the device must have been implanted at least 6 months before screening and the device parameters must be documented as stable for at least 1 month prior to screening. (Note: These devices will not be counted as concomitant AED).
• Except for epilepsy, subject is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory

You may not qualify if:

• Subjects with a prior exposure to ESL.
• Subjects currently being treated with OXC.
• Subject with a history of allergic reaction to OXC or CBZ, or a history of serious allergic reaction (Stevens-Johnson syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms or similar) to any AED, or a history of serious allergic reactions to other medications.
• Subjects who have taken warfarin, felbamate, vigabatrin, or perampanel, (unless at stable dose with safety testing for ≥ 1 year) within a 4-week period prior to screening.
• Subjects taking ezogabine
• Subject has taken any medication prohibited for this protocol within 4 weeks prior to Screening
• Subjects using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as an AED
• Seizure disorder characterized primarily by simple POS without motor signs.
• Subject has a history of primarily generalized seizures (eg, myoclonic, absence, tonic).
• Subject has a history of status epilepticus or cluster seizures (ie, 3 or more seizures within 30 minutes) within the 3 months prior to screening.
• Subject has had seizures of psychogenic origin or purely subjective seizures within the last 2 years.
• Subject has had seizures too close to count accurately.
• Subject has a known progressive structural central nervous system (CNS) lesion, progressive encephalopathy or any other condition that may result in epilepsy secondary to a cerebral abnormality.
• Subject whose current seizures are related to an acute medical illness or other non-epileptic origin.
• Subjects of Asian ancestry will be excluded if they are carriers of HLA-B\*1502. Either:

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (55)

University of South Alabaa Neurology Department

Mobile, Alabama, 36604, United States

Location

Banner University Medical Center Phoenix=Neuroscience Institute

Phoenix, Arizona, 85006, United States

Location

Rancho Research Institute, Inc.

Downey, California, 90242, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

University of California-Irvine

Orange, California, 92868, United States

Location

Blue Sky Neurology, a Division of Carepoint PC

Englewood, Colorado, 80113, United States

Location

University of Connecticut School of Mwdicine -UCONN Health

Farmington, Connecticut, 06030, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Boca Raton Regional Hospital, Marcus Neuroscience Institute

Boca Raton, Florida, 33486, United States

Location

Infinity Clinical Research, LLC

Hollywood, Florida, 33021, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

The Neurology Research Group, LLC

Miami, Florida, 33176, United States

Location

Laszlo J. Mate, MD, PA

North Palm Beach, Florida, 33408, United States

Location

Neurological Services of Orlando, PA

Orlando, Florida, 32806, United States

Location

Pedicatric Neurology, PA

Orlando, Florida, 32819, United States

Location

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Vero Beach Neurology And Reasearch Institue/The MS Center of Vero Beach

Vero Beach, Florida, 32960, United States

Location

Georgia Neurology and Sleep Medicine Associates

Suwanee, Georgia, 30042, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

Conslutants in Epilepsy & Neurology, PLLC

Boise, Idaho, 83702, United States

Location

Northwestern Medical Group, Deparment of Neurology

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Associates in Neurology, PSC

Lexington, Kentucky, 40513, United States

Location

University of Kentucky Hospital, Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

Balijeet Shethi, MD

Waldorf, Maryland, 20603, United States

Location

Wayne State University/Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

Minnesota Epilepsy Group, PA

Saint Paul, Minnesota, 55102, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

JFK Neuroscience Institute, JFK Medical Center

Edison, New Jersey, 08820, United States

Location

Clinical Research Center of NJ (CRCNJ)

Voorhees Township, New Jersey, 08043, United States

Location

NYU Winthrop Hospital, Clinical Trials Center

Mineola, New York, 11501, United States

Location

UNC Inverstigal Drug Services

Chapel Hill, North Carolina, 27514, United States

Location

The Neurological Institute, PA

Charlotte, North Carolina, 28204, United States

Location

Wake Forest Baptist Health Sciences, Department of Neurology

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Providence Medical Group-Medford Neurology

Medford, Oregon, 97504, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Alleghany General Hospital (Allegheny Neurological Association)

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt Epilepsy Clinic

Nashville, Tennessee, 37232, United States

Location

Austin Epilepsy Care Center

Austin, Texas, 78758, United States

Location

Aston Ambulatory Care Center

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center at San Antonio Medical Arts and Research Center

San Antonio, Texas, 78229, United States

Location

SSM Health Dean Medical Group

Madison, Wisconsin, 53715, United States

Location

Londo Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Clinique D'Épilepsie Neuro Rive-Sud

Greenfield Park, Quebec, J4V 2J2, Canada

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialdisclosure@sunovion.com

1-866-503-6351

Study Officials

• Sr. Director Medical Affairs

  Sumitomo Pharma America, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Arm 1 (ESL as first add-on) Arm 2 (ESL as later add-on)

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: July 7, 2017
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Locations

US (53); CA (2)