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View Clinical Trial (Medical Research Study)
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A Study to See the Effect of ICA-105665 in Photosensitive Epilepsy Patients - NCT00979004-72205 (Clinical Trial 331378)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy331378.aspx
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| City: |
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Little Rock |
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State:
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AR |
| Zip Code: |
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72205 |
| Conditions: |
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Photosensitive Epilepsy - Photosensitivity - Seizures - Epilepsy |
| Purpose: |
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The purpose of this study is to determine the effects of ICA-105665 on the photoparoxysmal
electroencephalography (EEG) response in photosensitive epilepsy patients exposed to
intermittent photic stimulation.
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| Study summary: |
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Subjects with epilepsy with a documented photoparoxysmal response to intermittent photic
stimulation 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 EEG response of each group will be reviewed before the dose is selected for
each subsequent group of subjects. |
| Criteria: |
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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 PI 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 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, AST ≥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
interpretation 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. |
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| Study is available at: |
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Little Rock, AR 72205
United States
Primary Contact:
Elizabeth Moore, M.S.
Email: emoore@icagen.com
Phone: 919 281-3955 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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