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

NCT00979004 | Terminated Phase 2

• 2 other identifiers: ICA-105665-04B5311005
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Epilepsy

Keywords

Photosensitivity; Epilepsy; Seizures

Outcome Measures

Primary Outcomes (1)

• Change in photosensitivity response

  begin 1 hr post dose for 8 hours

Secondary Outcomes (2)

• To correlate plasma concentrations of ICA-105665 with effect on the frequency range of IPS-induced PPR (Photoparoxysmal response) in subjects with photosensitive epilepsy.

  3 days

• To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy.

  30 days

Study Arms (1)

ICA-105665

EXPERIMENTAL

Drug: ICA-105665

Interventions

ICA-105665 DRUG

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.

ICA-105665

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Chesterfield, Missouri, 63017, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsy; Photosensitivity Disorders; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 4, 2012

Record last verified: 2012-09

Locations

US (3)