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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 16, 2009
First Posted Date  ICMJE September 17, 2009
Last Update Posted Date October 4, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
Change in photosensitivity response [ Time Frame: begin 1 hr post dose for 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • 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 ]
  • To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2009)
  • 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 ]
  • To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy. [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effect of ICA-105665 in Photosensitive Epilepsy Patients
Official Title  ICMJE A Phase 2, Multi-Center, Single-Blind, Placebo-Controlled Pharmacodynamic Evaluation of ICA-105665 in Epilepsy Patients With a Photo-Induced Paroxysmal EEG Response
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: ICA-105665
Intervention: Drug: ICA-105665
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 17, 2011)
13
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2009)
12
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00979004
Other Study ID Numbers  ICMJE ICA-105665-04
B5311005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP