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.

NCT00563459 | Terminated Phase 3 DMC

• 5 other identifiers: CR014317Carisbamate Retention StudyCaReSEudraCT # 2007-02929-78CARISEPY3007
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epilepsy; Seizures

Keywords

Epilepsy, seizures; partial onset seizures; anti-epileptic drugs (AED); carisbamate; topiramate; levetiracetam

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is time from the first intake of study medication to discontinuation (all causes) of study medication during the 6 month core double-blind phase.

  A six month period

Secondary Outcomes (5)

• Cognitive side effect profiles of CRS and TPM

  At 6 and 12 month periods

• Neuropsychiatric side effect profiles of CRS and LEV

  At 6 and 12 month periods

• Reasons for discontinuation among the 3 treatment arms

  At 6 and 12 month periods

• Seizures rates among the 3 treatment arms

  At 6 and 12 month periods

• Subject reported mood states, behavioral and cognitive side effect changes among the 3 treatment arms

  At 6 and 12 month periods

Study Arms (3)

001

EXPERIMENTAL

carisbamate 400-1200 mg/day for 12 months

Drug: carisbamate

002

ACTIVE COMPARATOR

topiramate 200-400mg/day for 12 months

Drug: topiramate

003

ACTIVE COMPARATOR

levetiracetam 1000-3000mg/day for 12 months

Drug: levetiracetam

Interventions

carisbamate DRUG

400-1200 mg/day for 12 months

001

topiramate DRUG

200-400mg/day for 12 months

002

levetiracetam DRUG

1000-3000mg/day for 12 months

003

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must weigh \>= 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 but no more than 120 partial onset seizures during the 3-month retrospective baseline period prior to screening
• History of monotherapy AED treatment failure at at least 1 but not more than 4 AEDs in the past
• 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
• Current AED treatment with at least 1 and no more than 2 AEDs given at a stable dose 30 days prior to screening
• 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.

You may not qualify if:

• 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 or West Syndrome
• More than 3 days of sedative or benzodiazepine use for seizures in the 3 months months prior to screening
• No clinical evidence of significant cardiac disease
• ALT \> 1.5 times the upper limit of normal or total bilirubin above the upper limit of normal at screen
• No history of drug-induced liver injury, diagnosis of any form of chronic liver disease, cirrhosis, or liver cancer nor positive hepatitis serology as determined by multiantigen enzyme immunoassay (EIA)
• No past or current with topiramate or levetiracetam for any reason
• No current use of vagal nerve stimulator
• 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.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol; Topiramate; Levetiracetam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 29, 2013

Record last verified: 2013-01