- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00979004
A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients
September 27, 2012 updated by: Pfizer
A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Pfizer Investigational Site
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Missouri
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Chesterfield, Missouri, United States, 63017
- Pfizer Investigational Site
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Tennessee
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Nashville, Tennessee, United States, 37232
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ICA-105665
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in photosensitivity response
Time Frame: begin 1 hr post dose for 8 hours
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begin 1 hr post dose for 8 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy.
Time Frame: 3 days
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3 days
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To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy.
Time Frame: 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 16, 2009
First Submitted That Met QC Criteria
September 16, 2009
First Posted (Estimate)
September 17, 2009
Study Record Updates
Last Update Posted (Estimate)
October 4, 2012
Last Update Submitted That Met QC Criteria
September 27, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICA-105665-04
- B5311005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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