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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 October 2014 |
Main ID: |
EUCTR2004-002069-19-BE |
Date of registration:
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20/12/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures - Not Applicable
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Scientific title:
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A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures - Not Applicable |
Date of first enrolment:
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26/04/2005 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002069-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Spain
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: Male or female between 18 and 70 years, inclusive.
Weight >/= 40 kg.
Diagnosis of epilepsy for at least 1 year.
History of partial onset seizures, including complex partial and/or partial with secondary generalization and/or simple partial motor seizures.
History of having failed the use of at least 3 different AEDs, administered at appropriate doses and for sufficient treatment periods
In the judgment of the investigator, a history of an established pattern of persistent seizures that approximates a frequency of at least 3 partial onset seizures per month.
Concomitant treatment with 1 to 3 AEDs. The AED doses must have been stable over the past month.
Female subjects of childbearing potential must have a negative serum pregnancy test at screening, and a negative urine pregnancy test at randomization (Day 1). Female subjects of childbearing potential must be practicing an effective method of birth control for at least 1 month prior to study entry and throughout the conduct of this trial.
Must have experienced at least 6 partial onset seizures during the prospective baseline.
Must have had no seizure-free interval of more than 4 weeks' duration at any time during the 8-week baseline phase.
Subjects may have complementary evidence for the diagnosis of partial epilepsy, including either imaging procedures or EEG, or both.
Subjects must have provided informed consent.
Subjects with a history (at any time in their life) of Stevens Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, a drug-related exfoliative rash, or any drug related rash requiring hospitalization will not be allowed to enter the open-label extension study EPY-2006. In addition, subjects with a history of rash associated with an AED that involved conjunctiva or mucosae, or a maculopapular rash that required discontinuation of an AED will not be allowed to enter Study EPY-2006. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: History of status epilepticus in the past 3 months.
Subjects who have seizures that cannot be quantitated accurately.
History of any nonepileptic seizures, either currently or in the past.
History of serious systemic disease
History of progressive neurologic disorder.
History of a major psychiatric disorder within the last 2 years.
Current treatment with VNS for less than 12 months, or VNS discontinuation within the past 3 months.
History of a ketogenic diet initiated within the past 3 months.
History of suicidal ideations or suicide attempt within the past 2 years.
History of drug or alcohol abuse within the past 2 years.
History of felbamate treatment within the past 90 days.
Current treatment with vigabatrin, or prior history of treatment with vigabatrin in the absence of reproducible visual field examinations that are deemed to be reliable by an ophthalmologist or neurophthalmologist.
Current treatment with tricyclic antidepressants, such as amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, maprotiline, nortriptyline, protriptyline, or trimipramine.
History of experimental drug or medical device use within 30 days before the planned start of treatment.
Female subjects of childbearing potential who are not using a reliable method of contraception, who are pregnant, or who are breastfeeding.
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Refractory partial epilepsy MedDRA version: 12.0
Level: LLT
Classification code 10061334
Term: Partial seizures
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Intervention(s)
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Product Name: RWJ-333369 100mg tablet Product Code: GFI-333369-000-CA-004 Pharmaceutical Form: Tablet INN or Proposed INN: carisbamate Current Sponsor code: RWJ-333369 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: RWJ-333369 200mg Tablet Product Code: GFI-333369-000-CA-005 Pharmaceutical Form: Tablet INN or Proposed INN: carisbamate Current Sponsor code: RWJ-333369 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: RWJ-333369 400mg Tablet Product Code: GFI-333369-000-CA-006 Pharmaceutical Form: Tablet INN or Proposed INN: carisbamate Current Sponsor code: RWJ-333369 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: RWJ-333369 50 mg tablet Product Code: GFI-333369-000-CA-007 Pharmaceutical Form: Tablet INN or Proposed INN: carisbamate Current Sponsor code: RWJ-333369 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
Product Name: RWJ-333369 600 mg Tablet Product Code: GFI-333369-000-CA-009 Pharmaceutical Form: Tablet INN or Proposed INN: carisbamate Current Sponsor code: RWJ-333369 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600-
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Primary Outcome(s)
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Primary end point(s): The primary efficacy variable is the percent reduction in seizure frequency (average monthly seizure rate) between the double-blind treatment and the pretreatment baseline, relative to the percent reduction observed for placebo.
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Secondary Objective: to evaluate the population pharmacokinetics of RWJ-333369 and to assess the effects of RWJ-333369 on the pharmacokinetics of concomitant AEDs (specifically oxcarbazepine [OXC], phenytoin [PHT], phenobarbital [PB], topiramate [TPM], CBZ, VPA, and LTG). The potential impact of genetic variation on efficacy and safety of RWJ-333369 will also be assessed in subjects who consent to DNA testing.
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Main Objective: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 (100, 300, 800, and 1.600 mg) as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive
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Secondary ID(s)
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2004-002069-19-GB
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Not available
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333369-EPY-2003/2006
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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