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

NCT ID: NCT00979004

Last Updated: 2012-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-09-30

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.

Conditions

Epilepsy

Keywords

Photosensitivity; Epilepsy; Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ICA-105665

Group Type: EXPERIMENTAL

ICA-105665

Intervention Type: DRUG

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.

Interventions

ICA-105665

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Little Rock, Arkansas, United States

Pfizer Investigational Site

Chesterfield, Missouri, United States

Pfizer Investigational Site

Nashville, Tennessee, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ICA-105665-04&StudyName=A%20Study%20to%20Investigate%20the%20Effect%20of%20ICA-105665%20in%20Photosensitive%20Epilepsy%20Patients

To obtain contact information for a study center near you, click here.

Other Identifiers

B5311005

Identifier Type: -

Identifier Source: secondary_id

ICA-105665-04

Identifier Type: -

Identifier Source: org_study_id