Photosensitive EpilepsyPhase 2NCT00579384
A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive Epilepsy
A Phase 2 study testing JNJ-26489112 in people with Photosensitive Epilepsy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to check the Effects of JNJ-26489112 on the Photic Induced Paroxysmal electroencephalogram (EEG) Response in Patients with Photosensitive Epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Photosensitive Epilepsy
- What is being tested?
- JNJ-26489112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Jul 2008
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or postmenopausal/surgically sterile females. Post-menopausal is defined as no menses for the 18 months prior to study start. If menses have ceased within 36 months of the start of this study, then plasma follicle stimulating hormone must be elevated to within a post-menopausal range at study screening
- Pre-menopausal surgically sterilized patients must have a negative beta chorionic gonadotropin pregnancy test at screening and at Day -2
- Women of childbearing potential may be enrolled when results of the reproductive toxicology studies become available, after review of that reproductive toxicology data and upon agreement of the Sponsor and Principal Investigator and the relevant local Ethics Committee, provided these women agree to utilize an acceptable method of birth control
- Body Mass Index (BMI) between 18.5 and 35 kg/m2 (inclusive)
- BMI= weight/height2
- Firm documented diagnosis of idiopathic, photosensitive epilepsy with a generalized photoparoxysmal EEG response
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- A photosensitive range in response to intermittent photic stimulation equal to or greater than 4 points in at least one eye condition at screening
- All values for hematology, coagulation, chemistry, and urinalysis within clinically acceptable ranges as they would be for healthy subjects prior to administration of study drug
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Male patients who are not sterile and are unwilling to use condoms for the duration of the study, ensure that their partner practices contraception or refrain from sexual intercourse (and until 90 days after the last dose of study medication).
Who cannot join
- History of liver or renal insufficiency
- significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (except epilepsy and febrile seizures), hematologic, psychiatric, or metabolic disturbances.
- Pregnant or lactating female or female insufficiently protected against pregnancy (for female patients of childbearing potential, a negative pregnancy test must be obtained and double-barrier method of contraception must be used starting from screening, throughout the study until follow-up visit), contingent upon satisfactory review of reproductive toxicology study results, and upon agreement of the Principal Investigator, the Sponsor, and the local Ethics Committee).
- Male subjects who are not sterile and are unwilling to use condoms for the duration of the study, ensure that their partner practices contraception or refrain from sexual intercourse (and until 90 days after the last dose of study medication).
- Any serious illness other than epilepsy.
- History of progressive neurological disorder, including brain tumor, active central nervous system infection, demyelinating disease, degenerative or progressive CNS disease.
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- Tonic-clonic seizure experienced in the 21-day period prior to Day 1 study drug dose administration (including Day -1).
- Use of herbal medication (including St. John's Wort, garlic extract and herbal teas) or mineral supplements within 14 days prior to study drug administration.
- Use of neuroleptics (typical or atypical) within 60 days prior to study drug administration.
- Use of more than two AEDs, or a change in antiepileptic medication within 30 days prior to study drug administration.
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or Human Immunodeficiency Virus (HIV) antibodies.
- Positive screen for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines). Note: Patients who currently take phenobarbital, mysoline or primidone as antiepileptic therapy and test positive for barbiturates are eligible for study participation. Patients who currently take vigabatrin or frisium as antiepileptic therapy and test positive for benzodiazepines are eligible for study participation.
- Recent history (within previous 6 months) of alcohol or drug abuse.
- Drinks, on average, more than 5 cups of tea/coffee/cocoa/cola per day.
- Smokes on average more than 10 cigarettes per day.
- Clinically significant acute illness within 7 days prior to study drug administration.
- Plasma donation within 7 days prior to study drug administration.
- Legal incapacity or limited legal capacity.
- Likely, in the investigator's opinion, not to cooperate with, or to respect the constraints of the study.
- Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.
- Have received an experimental drug or used an experimental medical device within 90 days before the planned start of treatment and/ or plan to use during the planned study participation.
- 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.
- Patients taking concomitant medications metabolized by CYP2C19 and/or CYP2B6.
About this study
Official title: A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram Response in Patients With Photosensitive Epilepsy
The purpose of this study is to check the Effects of JNJ-26489112 on the Photic Induced Paroxysmal electroencephalogram (EEG) Response in Patients with Photosensitive Epilepsy.
Read the detailed description
This is a multicenter, non-randomized (participants are assigned deliberately), single-blind (patients do not know which treatment they are receiving), within patient placebo-controlled study. Up to 32 male or female patients will participate in this study. The duration of subject participation is approximately 6 weeks.
Patients will receive the oral doses of study drug in the mornings of Days 1, 2, and 3. All patients will receive a single dose of placebo on Day 1, a single dose of JNJ-26489112 on Day 2, and a second single dose of placebo on Day 3. Blood samples will be taken for evaluation of JNJ-26489112 drug concentrations in plasma and blood. Blood samples will also be collected for laboratory safety assessments and measurement of antiepileptic drug concentrations. Further safety will be assessed by the reporting of adverse events, vital signs, 12-lead ECG, physical and neurological examinations. Patients will be discharged on the evening of Day 3 after the pharmacokinetic samples have been collected, and after assessment by the investigator, unless there are any ongoing adverse events which require in-house monitoring. EEG tracings, recorded during intermittent photic stimulation sessions, will be digitally recorded on a CD-ROM, coded and evaluated independently by one blinded clinical expert to determine the effects on the photosensitivity range. If complete suppression of photosensitivity or reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is not observed in at least 3 of the 4 patients and a maximum tolerated dose has been reached, the study will be stopped. If reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is observed in at least 3 of the 4 patients (with complete suppression in at least 2 patients) in the first cohort, the dose level of JNJ-26489112 may be reduced in subsequent cohorts until the reduction or suppression of photosensitivity is seen in fewer than 2 out of 4 patients in one cohort. Once an effective dose has been reached an additional open-label cohort may be enrolled in which no study drug (JNJ-26489112 or placebo) will be administered to patients. Study drug (i.e., JNJ-26489112 or placebo) will be administered orally as single doses on Days 1 to 3. Placebo will be administered on Days 1 and 3, and a single dose of JNJ-26489112 will be administered on Day 2.
- Conditions
- Photosensitive Epilepsy
- Being tested
- JNJ-26489112, Placebo
- Keywords
- Photosensitive epilepsy, Reflex epilepsy, Epilepsy, JNJ-26489112
- Medical subject headings
- Epilepsy, Reflex, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-26489112Drug
Single oral dose of JNJ-26489112 up to 3000 mg on Day 2.
PlaceboDrug
Single dose of placebo on Day 1, and a second single dose of placebo on Day 3.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Not described Receives: Drug: JNJ-26489112; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS).
Measured: Hours 1 to 8 (Day 2) and 25 to 33 postdose (Day 3) with optional assessments at 48, 52, and 56 hours postdose
Secondary outcomes (1)
The safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112.
Measured: Day 1 to Day 3 and an optional Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photosensitive EpilepsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579384
- Sponsor's protocol ID
- CR014110
- Other IDs
- 26489112NAP2001
- Status last verified
- Apr 2012
- First submitted
- 20 Dec 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram Response in Patients With Photosensitive Epilepsy
- ClinicalTrials.gov ID
- NCT00579384
- Acronym / sponsor ID
- CR014110
- Conditions
- Photosensitive Epilepsy
- Keywords
- Photosensitive epilepsy, Reflex epilepsy, Epilepsy, JNJ-26489112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Dec 2007 (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 this study is to check the Effects of JNJ-26489112 on the Photic Induced Paroxysmal electroencephalogram (EEG) Response in Patients with Photosensitive Epilepsy.
Detailed description
This is a multicenter, non-randomized (participants are assigned deliberately), single-blind (patients do not know which treatment they are receiving), within patient placebo-controlled study. Up to 32 male or female patients will participate in this study. The duration of subject participation is approximately 6 weeks.
Patients will receive the oral doses of study drug in the mornings of Days 1, 2, and 3. All patients will receive a single dose of placebo on Day 1, a single dose of JNJ-26489112 on Day 2, and a second single dose of placebo on Day 3. Blood samples will be taken for evaluation of JNJ-26489112 drug concentrations in plasma and blood. Blood samples will also be collected for laboratory safety assessments and measurement of antiepileptic drug concentrations. Further safety will be assessed by the reporting of adverse events, vital signs, 12-lead ECG, physical and neurological examinations. Patients will be discharged on the evening of Day 3 after the pharmacokinetic samples have been collected, and after assessment by the investigator, unless there are any ongoing adverse events which require in-house monitoring. EEG tracings, recorded during intermittent photic stimulation sessions, will be digitally recorded on a CD-ROM, coded and evaluated independently by one blinded clinical expert to determine the effects on the photosensitivity range. If complete suppression of photosensitivity or reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is not observed in at least 3 of the 4 patients and a maximum tolerated dose has been reached, the study will be stopped. If reduction of the photosensitivity range by at least 3 points on the photosensitivity scale in at least one eye condition (during closure, closed, open) is observed in at least 3 of the 4 patients (with complete suppression in at least 2 patients) in the first cohort, the dose level of JNJ-26489112 may be reduced in subsequent cohorts until the reduction or suppression of photosensitivity is seen in fewer than 2 out of 4 patients in one cohort. Once an effective dose has been reached an additional open-label cohort may be enrolled in which no study drug (JNJ-26489112 or placebo) will be administered to patients. Study drug (i.e., JNJ-26489112 or placebo) will be administered orally as single doses on Days 1 to 3. Placebo will be administered on Days 1 and 3, and a single dose of JNJ-26489112 will be administered on Day 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-26489112, Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Males or postmenopausal/surgically sterile females. Post-menopausal is defined as no menses for the 18 months prior to study start. If menses have ceased within 36 months of the start of this study, then plasma follicle stimulating hormone must be elevated to within a post-menopausal range at study screening
- Pre-menopausal surgically sterilized patients must have a negative beta chorionic gonadotropin pregnancy test at screening and at Day -2
- Women of childbearing potential may be enrolled when results of the reproductive toxicology studies become available, after review of that reproductive toxicology data and upon agreement of the Sponsor and Principal Investigator and the relevant local Ethics Committee, provided these women agree to utilize an acceptable method of birth control
- Body Mass Index (BMI) between 18.5 and 35 kg/m2 (inclusive)
- BMI= weight/height2
Key exclusion criteria (23 listed)
- History of liver or renal insufficiency
- significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (except epilepsy and febrile seizures), hematologic, psychiatric, or metabolic disturbances.
- Pregnant or lactating female or female insufficiently protected against pregnancy (for female patients of childbearing potential, a negative pregnancy test must be obtained and double-barrier method of contraception must be used starting from screening, throughout the study until follow-up visit), contingent upon satisfactory review of reproductive toxicology study results, and upon agreement of the Principal Investigator, the Sponsor, and the local Ethics Committee).
- Male subjects who are not sterile and are unwilling to use condoms for the duration of the study, ensure that their partner practices contraception or refrain from sexual intercourse (and until 90 days after the last dose of study medication).
- Any serious illness other than epilepsy.
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 |
|---|---|---|
| JNJ-26489112Single oral dose of JNJ-26489112 up to 3000 mg on Day 2. | Drug | 001 |
| PlaceboSingle dose of placebo on Day 1, and a second single dose of placebo on Day 3. | Drug | 001 |
Primary outcome
The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS).
Time frame: Hours 1 to 8 (Day 2) and 25 to 33 postdose (Day 3) with optional assessments at 48, 52, and 56 hours postdose
1 secondary outcome
The safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112.
Time frame: Day 1 to Day 3 and an optional Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-26489112 in people with Photosensitive Epilepsy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 10 inclusion and 23 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: finished, as of the sponsor's last update on 5 Apr 2012. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS). (time frame: Hours 1 to 8 (Day 2) and 25 to 33 postdose (Day 3) with optional assessments at 48, 52, and 56 hours postdose). 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 5 Apr 2012.