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

This study has been 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.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00979004
First received: September 16, 2009
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Epilepsy
Drug: ICA-105665
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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 (Photoparoxysmal response) 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 ]

Enrollment: 13
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00979004     History of Changes
Other Study ID Numbers: ICA-105665-04, B5311005
Study First Received: September 16, 2009
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Photosensitivity
Epilepsy
Seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Reflex
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014