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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2004-002069-19-ES |
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Date of registration:
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25/01/2006 |
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Prospective Registration:
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No |
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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
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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 |
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Date of first enrolment:
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13/04/2005 |
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Target sample size:
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500 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002069-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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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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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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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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Contacts
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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.
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 must have complementary evidence for the diagnosis of partial epilepsy, including either imaging procedures or EEG, or both.
Subjects must have provided informed consent.
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.
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
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Intervention(s)
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Product Name: RWJ-333369 100mg tablet
Product Code: 333369-000-C-019, F003
Pharmaceutical Form: Tablet
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: 333369-000-C-020, F004
Pharmaceutical Form: Tablet
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: 333369-000-C-15, F005
Pharmaceutical Form: Tablet
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: 333369-000-C-018, F002
Pharmaceutical Form: Tablet
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
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Primary Outcome(s)
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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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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:
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Secondary ID(s)
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2004-002069-19-GB
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333369-EPY-2003/2006
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 11/03/2005
Contact:
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