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A Study to See the Effect of ICA-105665 in Photosensitive Epilepsy Patients
This study is currently recruiting participants.
Verified by Icagen, February 2010
First Received: September 16, 2009   Last Updated: February 3, 2010   History of Changes
Sponsor: Icagen
Information provided by: Icagen
ClinicalTrials.gov Identifier: NCT00979004
  Purpose

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.


Condition Intervention Phase
Photosensitive Epilepsy
Photosensitivity
Seizures
Epilepsy
Drug: ICA-105665
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title: A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal Electroencephalographic (EEG) Response

Resource links provided by NLM:


Further study details as provided by Icagen:

Primary Outcome Measures:
  • Change in photosensitivity response [ Time Frame: begin 1 hr post dose for 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR in subjects with photosensitive epilepsy. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: September 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ICA-105665: Experimental 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 400 mg.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979004

Contacts
Contact: Elizabeth Moore, M.S. 919 281-3955 emoore@icagen.com

Locations
United States, Arkansas
Recruiting
Little Rock, Arkansas, United States, 72205
United States, Maryland
Recruiting
Baltimore, Maryland, United States, 21287
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 27215
Sponsors and Collaborators
Icagen
Investigators
Study Director: Seth V Hetherington, MD Icagen
  More Information

No publications provided

Responsible Party: Icagen, Inc. ( Seth Hetherington, M.D., Sr. VP Clinical and Regulatory Affairs )
Study ID Numbers: ICA-105665-04
Study First Received: September 16, 2009
Last Updated: February 3, 2010
ClinicalTrials.gov Identifier: NCT00979004     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Icagen:
Photosensitivity
Epilepsy
Seizures
Photosensitive epilepsy
AED
Photic stimulation

Additional relevant MeSH terms:
Epilepsy, Reflex
Signs and Symptoms
Epilepsy
Nervous System Diseases
Seizures
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010