A Study of the Effects of JNJ-26489112 on the Photic Induced Paroxysmal Electroencephalogram (EEG) Response in Patients With Photosensitive Epilepsy

NCT00579384 | Completed Phase 2

• 2 other identifiers: CR01411026489112NAP2001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Photosensitive Epilepsy

Keywords

Photosensitive epilepsy; Reflex epilepsy; Epilepsy; JNJ-26489112

Outcome Measures

Primary Outcomes (1)

• The photosensitivity range in each eye condition (during closure, closed, open) based upon the photoparoxysmal electroencepholgram (EEG) response to intermittent photic stimulation (IPS).

  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.

  Day 1 to Day 3 and an optional Day 4

Study Arms (1)

001

EXPERIMENTAL

Drug: JNJ-26489112; Drug: Placebo

Interventions

JNJ-26489112 DRUG

Single oral dose of JNJ-26489112 up to 3000 mg on Day 2.

001

Placebo DRUG

Single dose of placebo on Day 1, and a second single dose of placebo on Day 3.

001

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Epilepsy, Reflex; Epilepsy

Interventions

N-((6-chloro-2,3-dihydrobenzo(1,4)dioxin-2-yl)methyl)sulfamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: April 5, 2012

Record last verified: 2012-04