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An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy

Primary Purpose

Epilepsy, Epilepsies, Partial

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
RWJ 333369:
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Refractory partial epilepsy, seizure disorder, antiepileptic drugs

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: In order to enter the open label extension, the patient must have completed Study 333369EPY-2001. Exclusion Criteria: Patients who have seizures that cannot be quantitated accurately patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months patients with a history of drug or alcohol abuse within the past 2 years patients currently taking felbamate, vigabatrin, or tricyclic antidepressants and female patients who are pregnant or nursing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    001

    Arm Description

    RWJ 333369: Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor

    Outcomes

    Primary Outcome Measures

    Adverse events as a measure of safety and tolerability

    Secondary Outcome Measures

    Seizure counts

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    January 15, 2013
    Sponsor
    SK Life Science, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210652
    Brief Title
    An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy
    Official Title
    A Double-Blind, Placebo-Controlled, Dose-Titration Study to Determine Safety, Tolerability and Preliminary Efficacy of RWJ-333369 as Adjunctive Therapy in Subjects With Treatment-Resistant Partial Seizures (With or Without Secondary Generalization) or Primarily Generalized Tonic-Clonic Seizures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SK Life Science, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic drugs.
    Detailed Description
    333369EPY2002 is the open-label extension study that follows the double-blind study 333369EPY2001. In an open label study such as 333369EPY2002, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY2001, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of study 333369EPY2001 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369). RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy. Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase. During this transition phase (up to 21 days in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started. Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day. Patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor. Initial dose RWJ-333369 is 1 capsule (250 milligram (mg) taken twice daily. Dosage may be changed at weekly intervals. The maximum permitted dose will be 4 capsules (1000 mg), twice daily during dose titration. Double blind-treatment duration is up to 71 days with the option to continue treatment in an open-label study. Maximum dose in open-label study is 1200 mg/day

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Epilepsies, Partial
    Keywords
    Epilepsy, Refractory partial epilepsy, seizure disorder, antiepileptic drugs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    RWJ 333369: Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor
    Intervention Type
    Drug
    Intervention Name(s)
    RWJ 333369:
    Intervention Description
    Open-Label Extension: One 250mg tablet twice daily up to a total of 1200mg/day up until RWJ-33369 is available by prescription or study is terminated by sponsor
    Primary Outcome Measure Information:
    Title
    Adverse events as a measure of safety and tolerability
    Time Frame
    At followup visits every 3 months up to the time RWJ-333369 is available by prescription or study is terminated by sponsor
    Secondary Outcome Measure Information:
    Title
    Seizure counts
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: In order to enter the open label extension, the patient must have completed Study 333369EPY-2001. Exclusion Criteria: Patients who have seizures that cannot be quantitated accurately patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months patients with a history of drug or alcohol abuse within the past 2 years patients currently taking felbamate, vigabatrin, or tricyclic antidepressants and female patients who are pregnant or nursing.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy

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