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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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4 January 2022 |
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Main ID: |
EUCTR2006-003839-68-CZ |
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Date of registration:
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18/12/2006 |
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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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Partial Onset Seizures Followed by an Open-Label Extension Study
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Partial Onset Seizures Followed by an Open-Label Extension Study |
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Date of first enrolment:
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16/11/2006 |
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Target sample size:
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510 |
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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:2006-003839-68 |
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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:
Single blind:
Double blind: yes
Parallel group: yes
Cross over:
Other: yes
Other trial design description: Double-blind followed by open label phase
If controlled, specify comparator, Other Medicinial Product:
Placebo: yes
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Czech Republic
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Finland
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Germany
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Male or female aged 16 years or older, inclusive.
2. Weight of at least 35 kg.
3. Established diagnosis of partial epilepsy for at least 1 year, using ILAE criteria.
4. History of inadequate response to at least 1 AED.
5. Current treatment with at least 1 and no more than 2 AED's.
6. Have had at least 3 simple partial motor, complex partial, or secondarily generalized seizures per month, and no seizure-free interval for more than 3 weeks.
6. Post-menopausal females, or those using acceptable method of birth control.
Are the trial subjects under 18? yes
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:
1. History of status epilepticus within 6 months before study entry.
2. Generalized epileptic syndrome or having only absence, atonic/tonic, or simple partial sensory or other simple partial type seizures.
3. Lennox-Gastaut Syndrome
4. Current serious or medically unstable systemic diseases.
5. Current major depression, or history of suicide within last 2 years.
6. History of drug or alcohol abuse.
7. Positive for hepatitis B or C, or HIV/AIDS.
8. History of drug-induced liver injury, or diagnosis of any form of chronic liver disease.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Partial Onset Epilepsy Seizures
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Intervention(s)
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Product Code: RWJ-333369
Pharmaceutical Form: Tablet
CAS Number: 194085-75-1
Current Sponsor code: RWJ-333369
Other descriptive name: (S)-2-O-carbamoyl-1-O-chlorophenyl-ethanol
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 100/200/400-
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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Secondary Objective: - Proportion of subjects with > 50% reduction from the pre-treatment baseline phase in seizure frequency.
- Change relative to baseline in the Recovery (after seizures) composite score of the SSQ compared to the end of the double-blind treatment phase.
- Changes in overall and subscale scores of various outcome scales.
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Main Objective: Percent reduction in seizure frequency (average monthly seizure rate per 28 days) of all simple partial motor and/or complex partial, and/or secondarily generalized seizures during the double-blind treatment phase, relative to the pre-treatment phase.
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Primary end point(s): Change in frequency of partial onset seizures during the pre-treatment baseline phase and during the double-blind treatment phase. Subject diaries will be the source of all seizure data.
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Secondary ID(s)
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2006-003839-68-FI
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333369-EPY-3001/3004
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 01/11/2006
Contact:
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