SeizuresPhase 3NCT00697762
Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
A Phase 3 study testing RWJ-333369 in people with Seizures, run by SK Life Science, Inc..
Trial summary
The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369 at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial epilepsy patients who have poor seizure control with one or two antiepileptics (AEDs). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Seizures
- What is being tested?
- RWJ-333369
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to May 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Body weight of 40 kg or more
- Established diagnosis of partial epilepsy for at least 1 year
- Current treatment with at least one and no more than two antiepileptics (AEDs)
- At least 6 episodes of simple partial motor seizures, complex partial seizures, or secondarily generalized seizures for 2 months (56 days) during the baseline period (No seizure free interval for more than 3 weeks)
Who cannot join
- Diagnosis of status epilepticus or epilepsia partialis continua within 6 months
- Patients with generalized epileptic syndrome
- Current or previous history of non-epileptic seizures, including psychogenic seizures
- Current or previous history of any serious or medically relevant systemic disease, including clinically apparent hepatic disease, renal failure, malignant neoplasm, insulin-requiring diabetes mellitus, or any disorder
- Patients with clinical evidence of significant cardiac disease
- Current or past (within 1 year) major significant psychotic disorder
- Have an ALT (GPT) greater than 1.5 times the upper reference limit or total bilirubin above the upper reference limit at screening laboratory tests
About this study
Official title: A Double-Blind Study to Evaluate the Effectiveness and Safety of RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369 at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial epilepsy patients who have poor seizure control with one or two antiepileptics (AEDs).
Read the detailed description
Despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. This is a multicenter, placebo-controlled, double-blind (neither the study physician nor the patient knows the name of the study assigned medication), randomized (study drug assigned by chance), parallel-group study. It consists of three periods: Pretreatment Phase (screening and baseline periods), Double-Blind Treatment Phase, and Posttreatment Phase (transitional period or dose-tapering/withdrawal period). Patients who complete Double-Blind Treatment Phase will be qualified to participate in the long-term extension study (Study 333369-KJ-03) following the present study. The primary hypothesis is that at 400mg/day of RWJ-333369 is effective in the adjunctive treatment of patients with partial onset epilepsy, as measured by the percent reduction from baseline in monthly seizure frequency of partial onset seizures. Safety is evaluated based on the following variables; Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist. Patients will receive the assigned dose (placebo, 200 mg/day, or 400 mg/day) twice daily orally for 12 weeks (85 days)
- Conditions
- Seizures
- Being tested
- RWJ-333369, Placebo
- Keywords
- Partial onset seizure, Adjunctive therapy
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RWJ-333369Drug
200 mg tablet twice daily for 12 weeks
RWJ-333369Drug
100 mg tablet twice daily for 12 weeks
PlaceboDrug
Placebo tablet twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 003 | Placebo comparator | Placebo tablet twice daily for 12 weeks Receives: Drug: Placebo |
| 002 | Experimental | RWJ-333369 200 mg tablet twice daily for 12 weeks Receives: Drug: RWJ-333369 |
| 001 | Experimental | RWJ-333369 100 mg tablet twice daily for 12 weeks Receives: Drug: RWJ-333369 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in partial seizure frequency (including simple partial motor seizures, complex partial seizures, and secondarily generalized seizures) for Double-Blind Treatment Phase from the baseline period
Measured: From begining to end of Double-Blind Treatment Phase (for 12 weeks).
Secondary outcomes (1)
50% responder rate: The proportion of patients with a 50% reduction or more in the number of partial seizures for Double-Blind Treatment Phase from Pretreatment Phase (baseline period)
Measured: From begining to end of Double-Blind Treatment Phase (for 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: The trial was stopped based on information from the global phase 3 studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697762
- Sponsor's protocol ID
- CR014284
- Other IDs
- 333369-KJ-02
- Status last verified
- Jan 2013
- First submitted
- 12 Jun 2008
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Study to Evaluate the Effectiveness and Safety of RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT00697762
- Acronym / sponsor ID
- CR014284
- Conditions
- Seizures
- Keywords
- Partial onset seizure, Adjunctive therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped based on information from the global phase 3 studies.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness and safety of adjunctive RWJ-333369 at a dose of 200 or 400 mg/day in comparison with placebo in Korean and Japanese partial epilepsy patients who have poor seizure control with one or two antiepileptics (AEDs).
Detailed description
Despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. This is a multicenter, placebo-controlled, double-blind (neither the study physician nor the patient knows the name of the study assigned medication), randomized (study drug assigned by chance), parallel-group study. It consists of three periods: Pretreatment Phase (screening and baseline periods), Double-Blind Treatment Phase, and Posttreatment Phase (transitional period or dose-tapering/withdrawal period). Patients who complete Double-Blind Treatment Phase will be qualified to participate in the long-term extension study (Study 333369-KJ-03) following the present study. The primary hypothesis is that at 400mg/day of RWJ-333369 is effective in the adjunctive treatment of patients with partial onset epilepsy, as measured by the percent reduction from baseline in monthly seizure frequency of partial onset seizures. Safety is evaluated based on the following variables; Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist. Patients will receive the assigned dose (placebo, 200 mg/day, or 400 mg/day) twice daily orally for 12 weeks (85 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 003 | Placebo comparator | Drug: PlaceboPlacebo tablet twice daily for 12 weeks |
| 002 | Experimental | Drug: RWJ-333369RWJ-333369 200 mg tablet twice daily for 12 weeks |
| 001 | Experimental | Drug: RWJ-333369RWJ-333369 100 mg tablet twice daily for 12 weeks |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Body weight of 40 kg or more
- Established diagnosis of partial epilepsy for at least 1 year
- Current treatment with at least one and no more than two antiepileptics (AEDs)
- At least 6 episodes of simple partial motor seizures, complex partial seizures, or secondarily generalized seizures for 2 months (56 days) during the baseline period (No seizure free interval for more than 3 weeks)
Key exclusion criteria (7 listed)
- Diagnosis of status epilepticus or epilepsia partialis continua within 6 months
- Patients with generalized epileptic syndrome
- Current or previous history of non-epileptic seizures, including psychogenic seizures
- Current or previous history of any serious or medically relevant systemic disease, including clinically apparent hepatic disease, renal failure, malignant neoplasm, insulin-requiring diabetes mellitus, or any disorder
- Patients with clinical evidence of significant cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RWJ-333369200 mg tablet twice daily for 12 weeks | Drug | 002 |
| RWJ-333369100 mg tablet twice daily for 12 weeks | Drug | 001 |
| PlaceboPlacebo tablet twice daily for 12 weeks | Drug | 003 |
Primary outcome
Percent reduction in partial seizure frequency (including simple partial motor seizures, complex partial seizures, and secondarily generalized seizures) for Double-Blind Treatment Phase from the baseline period
Time frame: From begining to end of Double-Blind Treatment Phase (for 12 weeks).
1 secondary outcome
50% responder rate: The proportion of patients with a 50% reduction or more in the number of partial seizures for Double-Blind Treatment Phase from Pretreatment Phase (baseline period)
Time frame: From begining to end of Double-Blind Treatment Phase (for 12 weeks).
Results and safety
The study was stopped early (reason given: The trial was stopped based on information from the global phase 3 studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RWJ-333369 in people with Seizures, run by SK Life Science, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was stopped based on information from the global phase 3 studies.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in partial seizure frequency (including simple partial motor seizures, complex partial seizures, and secondarily generalized seizures) for Double-Blind Treatment Phase from the baseline period (time frame: From begining to end of Double-Blind Treatment Phase (for 12 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.