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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 April 2022 |
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Main ID: |
EUCTR2007-004254-93-FR |
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Date of registration:
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28/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Non-Randomized, Within Subject Placebo-Controlled Exploratory Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal EEG Response in Subjects with Photosensitive Epilepsy - N/A
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Scientific title:
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A Non-Randomized, Within Subject Placebo-Controlled Exploratory Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal EEG Response in Subjects with Photosensitive Epilepsy - N/A |
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Date of first enrolment:
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20/11/2007 |
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Target sample size:
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32 |
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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:2007-004254-93 |
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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: no
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Within subject placebo controlled
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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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Males or postmenopausal/surgically sterile females between 18 and 60 years of age, inclusive. Body Mass Index (BMI) between 18.5 and 35 kg/m2 (inclusive); BMI= weight/height squared.
Firm documented diagnosis of idiopathic, photosensitive epilepsy with a generalized photoparoxysmal EEG response
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 Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
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).
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
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 subjects 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).
Any serious illness other than epilepsy.
History of progressive neurological disorder, including brain tumor, active CNS infection, demyelinating disease, degenerative or progressive CNS disease.
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: Subjects who currently take phenobarbital, mysoline or primidone as antiepileptic therapy and test positive for barbiturates are eligible for study participation. Subjects 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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Epilepsy
MedDRA version: 8.1
Level: LLT
Classification code 10015037
Term: Epilepsy
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Intervention(s)
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Product Name: JNJ-26489112 100mg/mL
Product Code: JNJ-26489112-AAA
Pharmaceutical Form: Oral suspension
Current Sponsor code: JNJ-26489112-AAA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective:
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Main Objective: To determine oral doses of JNJ-26489112 that result in complete suppression or reduction of IPS induced photoparoxysmal-EEG response, a marker of antiepileptic activity. To assess the safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112 in subjects with photosensitive epilepsy.
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Primary end point(s): Complete suppression or 3 point reduction in the IPS sensitivity range in 3 out of 4 subjects (with at least 2 having complete suppression of photosensitivity) will be considered as valid evidence of antiepileptic activity of JNJ-26489112 at the dose level(s) at which this occurs.
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Secondary ID(s)
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26489112NAP2001 INT-1
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 13/11/2007
Contact:
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