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

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



Sponsors


Source

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

Oversight Info

Has Dmc

No


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.

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.

Overall Status

Completed

Start Date

2007-10-01

Completion Date

2008-07-01

Primary Completion Date

2008-07-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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 Outcome

Measure

Time Frame

The safety, tolerability, pharmacokinetics and pharmacokinetic/pharmacodynamic relationship of JNJ-26489112.
Day 1 to Day 3 and an optional Day 4

Enrollment

12

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

001


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

001



Eligibility

Criteria

Inclusion Criteria:

- 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).

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 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.

- 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.

Gender

All

Minimum Age

18 Years

Maximum Age

60 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Verification Date

2012-04-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Name Title

Associate Director, Experimental Medicine

Organization

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


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

26489112NAP2001

Number Of Arms

1

Arm Group

Arm Group Label

001

Arm Group Type

Experimental


Firstreceived Results Date

N/A

Removed Countries

Country

France

United States



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Single Group Assignment

Primary Purpose

Treatment

Masking

Single (Participant)


Study First Submitted

December 20, 2007

Study First Submitted Qc

December 20, 2007

Study First Posted

December 24, 2007

Last Update Submitted

April 3, 2012

Last Update Submitted Qc

April 3, 2012

Last Update Posted

April 5, 2012

Disposition First Submitted

August 12, 2011

Disposition First Submitted Qc

August 12, 2011

Disposition First Posted

August 17, 2011


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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