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Trial record 12 of 12 for:    "Photosensitive Epilepsy"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00979004
Recruitment Status : Terminated (The study was terminated on September 12, 2010 per protocol following a serious adverse event that occurred with the first subject dosed at 600 mg.)
First Posted : September 17, 2009
Last Update Posted : October 4, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: ICA-105665 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: ICA-105665 Drug: 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.

Primary Outcome Measures :
  1. Change in photosensitivity response [ Time Frame: begin 1 hr post dose for 8 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00979004

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United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, Missouri
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63017
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT00979004     History of Changes
Other Study ID Numbers: ICA-105665-04
First Posted: September 17, 2009    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: September 2012

Keywords provided by Pfizer:

Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases