Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-Epileptic Drugs (AEDs) in Patients With Epilepsy.

Condition(s) targeted: Seizures; Epilepsy

Intervention: levetiracetam (Drug); Carisbamate (Drug); topiramate (Drug)

Phase: Phase 3

Status: Suspended

Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC

The purpose of this research study is to compare the long term effectiveness, safety and tolerability of carisbamate compared to two other frequently prescribed anti-epileptic drugs (AEDs) in patients with epilepsy.

Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects With Partial Onset Seizures

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Efficacy Study

Primary outcome: The primary outcome variable is long term retention rate and safety of adjunctive therapy with carisbamate vs. topiramate and levetiracetam over a six month period.

Secondary outcome: Secondary study endpoints include: incidence of psychiatric, cognitive and behavior side effects, and seizure rates.

Detailed description: The hypothesis is that the 3 study medications, based on their distinct efficacy and side effect profiles, will lead to statistically significant differences in the tolerability and retention rates of patients with partial onset seizures. This is a randomized, double-blind, parallel-group, active-comparator, multi-center study. The study consists of 5 phases: pretreatment (screening), double-blind titration phase, double blind maintenance phase, a taper/conversion phase, and an open-label phase. Patients who are not eligible or choose not to enter the taper/conversion and open-label phases of the study will complete an exit phase following double-blind treatment. The primary outcome variable is long term retention rate and safety of adjunctive therapy with carisbamate vs. topiramate and levetiracetam over a six month period. Safety evaluations including adverse event monitoring, blood tests, and vital signs will be conducted throughout the study.

Patients must be on at least 1, but not more than 2, baseline AEDs for 30 days prior to screening. Carisbamate, topiramate and levetiracetam will be administered orally in 2 equally divided doses of 400 mg/day, 300 mg/day, and 2000 mg/day respectively. At the end of week 8 patients must have reached the following minimum dosages of study drug to be permitted to continue: carisbamate 300 mg/day, topiramate 200 mg/day, levetiracetam 1000 mg/day. Double-blind phases last approximately 12 months.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must weigh at least 45 kg (~100lbs)

- Established diagnosis, for at least 3 months prior to screening, of partial onset

seizures, including simple partial motor, complex partial, or secondarily generalized seizures

- At least 1 partial onset seizure during the 3-month retrospective baseline period

prior to screening

- Females must be postmenopausal for at least 2 years, surgically sterile, abstinent,

or, if sexually active, practicing an acceptable method of birth control (eg, intrauterine device, double barrier method, male partner sterilization) before entry and throughout the study

- Females must have a negative serum beta chorionic gonadotropin pregnancy test result

at screening/randomization

- For adolescents (as defined by local regulations), a responsible person must be

available to accompany the patient to the study center at each visit, to provide reliable information for the safety and effectiveness evaluations, and to accurately and reliably dispense the study drug as directed, if required in the opinion of the investigator

Exclusion Criteria:

- Must not have a generalized epileptic syndrome, primary generalized seizures, atonic

seizures, typical or atypical absence seizures nor only simple partial type seizures with manifestations other than motor symptoms (i. e, simple partial sensory)

- No history of unprovoked status epilepticus in the last 6 months prior to screening

nor history of Lennox-Gastaut Syndrome

- No clinical evidence of significant cardiac disease

- No history of drug-induced liver injury, severe drug-induced hypersensitivity

reactions, diagnosis of any form of chronic liver disease, cirrhosis, or liver cancer nor positive hepatitis serology as determined by multiantigen enzyme immunoassay (EIA)

- Has not failed, in the judgment of the investigator, an adequate treatment attempt

(dose and duration) with topiramate or levetiracetam due to lack of effectiveness or tolerability (or other medications with equivalent international non-proprietary names)

- Not currently (within the past 30 days prior to screening) taking topiramate or

levetiracetam (or other medications with equivalent international non-proprietary names)

- No diagnosis of psychotic disorder, bipolar disease, or major depression or other

neurologic conditions, serious or medically unstable systemic disease, suicidal ideation or attempts, or homicide attempts at any time in the past 2 years

- Unable to swallow solid oral dosage forms whole with the aid of water (patients may

not chew, divide, dissolve, or crush the study drug)

- Anyone who falls under the precautions, warnings or contraindications outlined in the

local topiramate and/or local levetiracetam package insert

Hasselt 3500, Belgium

Duffel 2570, Belgium

Gent 9000, Belgium

Kortrijk 8500, Belgium

Brussel 1200, Belgium

Praha 5 150 06, Czech Republic

Praha 1 110 00, Czech Republic

Brno 625 00, Czech Republic

Ostrava 722 00, Czech Republic

Praha 2 128 21, Czech Republic

Brno 65691, Czech Republic

Olomouc N/A 775 20, Czech Republic

Tampere 33520, Finland

Turku 20110, Finland

Mikkeli, Finland

Kuopio 70210, Finland

Dijon 21000, France

Strasbourg 67091, France

Toulouse 31403, France

Rennes Cedex 35033, France

Lyon 69003, France

New Delhi 110029, India

Pune 411004, India

Maharai 400026, India

Mumbai 400020, India

Tirupati Andh Prad 517507, India

Karnad 560054, India

Maharai, India

New Delhi 110002, India

Madurai, India

Karnad 575018, India

Ahmedabad 380006, India

Hyderabad Andh Prad 500033, India

Chennai, India

Chennai 600006, India

Mangalore 575002, India

Hyderabad Andh Prad 500082, India

New Delhi 110016, India

Vishakhapatnam Andh Prad 530002, India

Kolkata 700054, India

Warszawa 02-957, Poland

Lodz 90-369, Poland

Lublin 20-950, Poland

Katowice 40-635, Poland

Gliwice, Poland

Lodz 93-509, Poland

Lublin 20-954, Poland

Kielce 25-736, Poland

Lodz 90-710, Poland

Warszawa 03-464, Poland

Moscow 129110, Russian Federation

St Petersburg, Russian Federation

Nizhny Novgorod 603115, Russian Federation

Kazan 420101, Russian Federation

Nizhny Novgorod 603163, Russian Federation

Russia St-Petersburg, Russian Federation

Yaroslavl 150030, Russian Federation

Moscow 107150, Russian Federation

Smolensk 214018, Russian Federation

Richards Bay Kz-Natal 7300, South Africa

Cape Town West Cape 7925, South Africa

Parktown Gauteng 2193, South Africa

Pretoria Gauteng 0041, South Africa

Johannesburg Gauteng 2196, South Africa

Umhlanga Kz-Natal 4321, South Africa

Barcelona, Spain

Barcelona 08025, Spain

Ankara 06590, Turkey

Adana 01330, Turkey

Manisa 45040, Turkey

Gorukle-Bursa 16059, Turkey

Izmir 35340, Turkey

Istanbul 34098, Turkey

Istanbul, Turkey

Manchester M6 8HD, United Kingdom

Bucks SL9 0RJ, United Kingdom

Glasgow G51 4TF, United Kingdom

Blackpool FY3 8BP, United Kingdom

Oxford OX2 6HE, United Kingdom

Tuscaloosa, Alabama 35406, United States

Northport, Alabama 35476, United States

Tucson, Arizona 85741, United States

Phoenix, Arizona 85013, United States

Gilbert, Arizona 85234, United States

Tucson, Arizona 85712, United States

Little Rock, Arkansas 72205, United States

Fayetteville, Arkansas 72703, United States

Garden Grove, California 92845, United States

Reseda, California 91335, United States

Santa Monica, California 90404, United States

Fort Collins, Colorado 80524, United States

Newark, Delaware 19713, United States

Washington, District of Columbia 20010, United States

Bradenton, Florida 34205, United States

Pensacola, Florida 32503, United States

Panama City, Florida 32405, United States

Maitland, Florida 32751, United States

Miami, Florida 33156, United States

Jacksonville, Florida 32209, United States

Ft Lauderdale, Florida 33308, United States

Sarasota, Florida 34233, United States

Atlanta, Georgia 30342, United States

Rome, Georgia 30165, United States

Savannah, Georgia 31405, United States

Canton, Georgia 30114, United States

Columbus, Georgia 31904, United States

Boise, Idaho 83702, United States

Indianapolis, Indiana 46256, United States

Danville, Indiana 46122, United States

Ames, Iowa 50010, United States

Lexington, Kentucky 40536, United States

Lexington, Kentucky 40513, United States

Rockville, Maryland 20850, United States

Boston, Massachusetts 02115, United States

Traverse City, Michigan 49684, United States

Detroit, Michigan 48201, United States

Saint Clair Shores, Michigan 48080, United States

Golden Valley, Minnesota 55422, United States

Hattiesburg, Mississippi 39401, United States

Chesterfield, Missouri 63017, United States

Saint Louis, Missouri 63104, United States

New Brunswick, New Jersey 08901, United States

Toms River, New Jersey 08755, United States

Warren, New Jersey 07059, United States

Buffalo, New York 14209, United States

Syracuse, New York 13210, United States

Bronx, New York 10467, United States

Albany, New York 12208, United States

New York, New York 10128, United States

Greensboro, North Carolina 27401, United States

Charlotte, North Carolina 28204, United States

Greenville, North Carolina 27834, United States

Toledo, Ohio 43614, United States

Oklahoma City, Oklahoma 73112, United States

Sellersville, Pennsylvania 18960, United States

Philadelphia, Pennsylvania 19107, United States

Philadelphia, Pennsylvania 19140, United States

Charleston, South Carolina 29425, United States

Orangeburg, South Carolina 29118, United States

Nashville, Tennessee 37208, United States

Cordova, Tennessee 38018, United States

Memphis, Tennessee 38104, United States

Hermitage, Tennessee 37076, United States

Germantown, Tennessee 38139, United States

Odessa, Texas 79761, United States

Houston, Texas 77004, United States

San Antonio, Texas 78229, United States

Houston, Texas 77005, United States

Brownwood, Texas 76801, United States

El Paso, Texas 79905, United States

Spring, Texas 77379, United States

Dallas, Texas 75214, United States

Richmond, Virginia 23229, United States

Alexandria, Virginia 22304, United States

Milwaukee, Wisconsin 53226, United States

Milwaukee, Wisconsin 53215, United States

To learn how to participate in this trial please click here.

Starting date: October 2007
Ending date: April 2009
Last updated: March 21, 2008