Status:
TERMINATED
A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients
Lead Sponsor:
Pfizer
Conditions:
Epilepsy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00979004
Start Date
September 1 2009
End Date
September 1 2010
Last Update
October 4 2012
Active Locations (3)
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1
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
2
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63017
3
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232