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Photosensitivity Proof of Concept Trial

NCT00894010 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2012-03-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether patients who usually have abnormal electrical EEG responses when shown flashing lights will show a reduction in abnormal electrical activity when they take a single dose of 2 marketed drugs (carbamazepine and levetiracetam). If so, a similar study in the future may be able to identify promising new drugs for epilepsy.

Patients who successfully complete the screening visit, will return 4 additional times and will receive either placebo (2 times) or a single oral dose of both carbamazepine 400mg and levetiracetam 1000mg in random order.

During each of the study days, several procedures and intermittent photosensitivity (IPS) assessments will be performed at 5 pre-determined times over the course of the day, one pre-dose and 4 post-dose.

Conditions

  • Photosensitive Epilepsy

Interventions

DRUG

carbamazepine 400mg

DRUG

levetiracetam 1000mg

Sponsors & Collaborators

  • The Epilepsy Research Foundation

    collaborator UNKNOWN

  • GlaxoSmithKline

    collaborator INDUSTRY

  • The Epilepsy Study Consortium

    lead OTHER

Principal Investigators

  • Jacqueline French, M.D. · NYU Comprehensive Epilepsy Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894010 on ClinicalTrials.gov