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

Last updated on February 17, 2019

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Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Epilepsy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00979004
Pfizer
Terminated
A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients

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1-800-718-1021

[email protected]

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