An open label study to evaluate the efficacy, safety and tolerability of RWJ333369 as adjunctive therapy in subjects with partial onset seizure

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-001801-99-HU
• Date of registration: 04/06/2007
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: An open label study to evaluate the efficacy, safety and tolerability of RWJ333369 as adjunctive therapy in subjects with partial onset seizure
• Scientific title: An open label study to evaluate the efficacy, safety and tolerability of RWJ333369 as adjunctive therapy in subjects with partial onset seizure
• Date of first enrolment: 13/08/2007
• Target sample size: 510
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001801-99
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: no Other:

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
For the double blind trial 3002:
1. Male or female aged 16 years or older, inclusive. 2. Weight of at least 40 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.
Inclusion criteria for study 3004:
subject must complete the 12-week double-blind treatment phase of study 333369-EPY-3002
subject must have signed a separate informed consent form for open-label extension study (333369-EPY-3004)
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

Health Condition(s) or Problem(s) studied

Partial Onset Epilepsy Seizures

Intervention(s)

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-

Primary Outcome(s)

Main Objective: The primary objective of this open label study is to determine the long-term safety and tolerability of RWJ-333369 as adjunctive treatment of partial onset seizures. Safety evaluation will include worsening of seizures, including rates of status epilepticus.

Primary end point(s): The primary objective of this study is to determine the long-term safety and tolerability of RWJ-333369 as adjunctive treatment of partial onset seizure. Safety evaluation will include worsening of seizures, including rates of status epilepticus.
Subject diaries will be the source of all seizure data.

Secondary Objective: The secondary objective of this study to determine health-related status as measured by the Quality of Life in Epilepsy-31 problems (QOLIE-31-P) outcomes scale.

Secondary ID(s)

333369EPY3004