A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients

Study Overview
=================
Brief Summary
-----------------
Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic stimulation (IPS) will participate. Four subjects will be enrolled at each dose level and will receive a single dose of placebo and a single dose of ICA-105665 during the study, each followed by intermittent photic stimulation. The effects of ICA-105665 on the photoparoxysmal electroencephalography (EEG) response of each group will be reviewed before the dose is selected for each subsequent group of subjects.

Official Title
-----------------
A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: ICA-105665


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis and history of epilepsy for which they are on 0-2 concurrent antiepileptic drugs. On a stable dose of their current AED(s) for 4 weeks prior to the Screening Visit. Must be in good health (with the exception of epilepsy), as determined by the Primary Investigator via the medical history, a physical examination, and screening laboratory investigations. A body mass index (BMI) between 18 and 35. Able and willing to give written informed consent prior to participation in the study. A reproducible IPS-induced photo-paroxysmal EEG response (PPR) of at least 3 points on a frequency assessment scale in at least one eye condition and no change of more than 3 frequencies in 2 repeated measurements recorded at the Screening Visit. Exclusion Criteria: History of non-epileptic seizures (metabolic, structural, or pseudoseizures). History of status epilepticus while on any antiepileptic medication. The etiology of the seizures is due to any of the following; progressive degenerative disease, metabolic illness, active infection, demyelination, drugs, alcohol. The subject has used benzodiazepines (oral, intra-muscular, or suppository) as escape medication within the past 6 months. The subject has taken an investigational medication within 30 days prior to the Day 1. Women who are pregnant or lactating. An active Central Nervous System (CNS) infection, demyelinating disease, degenerative neurological disease or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results. The subject has a clinically significant (e.g., cancerous, unstable, progressive, functionally disabling, or infectious) medical condition that would interfere with the ability to complete the study or that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs. Subjects with impaired hepatic function [ALT (Alanine aminotransferase), AST (Aspartate aminotransferase) =3 times the upper limit of normal] or any clinically significant laboratory abnormality that, in the opinion of the investigator, would increase the risk of participation or interfere with the interpretatio of the study results. History of alcoholism, drug abuse, or drug addiction within the last 12 months. Clinically significant psychiatric illness, psychological or behavioral problem which, in the opinion of the investigator would interfere with the subject's ability to participate in the study OR the subject is receiving therapy with neuroleptic drugs. Subject experiences a clinical seizure during any IPS procedure performed during the screening period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICA-105665<br> | Drug: ICA-105665<br>* Oral tablet. Dose forms of 50 and 100 mg or placebo will be used. A single dose will be administered that can range from placebo or 100 to 600 mg.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in photosensitivity response |  | begin 1 hr post dose for 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy. |  | 3 days | 
| To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photosensitivity, Epilepsy, Seizures