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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00979004
• Other study ID #: ICA-105665-04
• Secondary ID: B5311005
• Status: Terminated
• Phase: Phase 2
• First received: September 16, 2009
• Last updated: September 27, 2012
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chesterfield	Missouri
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in photosensitivity response		begin 1 hr post dose for 8 hours	No
Secondary	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	No
Secondary	To assess the safety of a single dose of ICA-105665 in subjects with photosensitive epilepsy.		30 days	Yes

External Links

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