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Photosensitivity Proof of Concept Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894010
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : March 5, 2012
The Epilepsy Research Foundation
Information provided by (Responsible Party):
The Epilepsy Study Consortium

Brief 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.

Condition or disease Intervention/treatment Phase
Photosensitive Epilepsy Drug: carbamazepine 400mg Drug: levetiracetam 1000mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial
Study Start Date : May 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Intervention Details:
  • Drug: carbamazepine 400mg
    Other Name: Tegretol
  • Drug: levetiracetam 1000mg
    Other Name: Keppra

Primary Outcome Measures :
  1. Demonstrate the ability of carbamazepine to suppress or reduce the photosensitivity response in patients with photosensitive epilepsy. Compare the ability of carbamazepine to impact the PPR as compared with levetiracetam, which is known to suppress PPR. [ Time Frame: At the completion of each cohort. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female age 18-60 years.
  • A diagnosis and history of a photoparoxysmal response on EEG with or without a diagnosis of epilepsy for which patients are on 0-1 concomitant antiepileptic drugs.
  • A reproducible IPS-induced photo-paroxysmal response (PPR) on EEG 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 screen in at least one eye condition.
  • Patients in otherwise good health (with the exception of epilepsy), as determined by the PI via the medical history, a physical examination and screening laboratory investigations.
  • A body mass index (BMI) between 18 and 35.
  • Able and willing to provide written informed consent to participate in the study in accordance with the ICH, GCP guidelines.

Exclusion Criteria:

  • A history of non epileptic seizures (e.g. metabolic, structural or pseudo-seizures).
  • Women who are pregnant or lactating.
  • Women of reproductive potential who do not agree to use effective birth-control methods.
  • Any clinically significant laboratory abnormality which, in the opinion of the investigator, will exclude the patient from the study.
  • An active 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.
  • Any clinically significant psychiatric illness, psychological or behavioral problems which, in the opinion of the investigator, would interfere with the patient's ability to participate in the study.
  • Patients who have a history of seizure worsening in response to narrow spectrum drugs (including carbamazepine)
  • Patients who are suffering from clinically significant active liver disease, porphyria or with a family history of severe hepatic dysfunction indicated by abnormal liver function tests greater than 3 times the upper limit of normal (AST and ALT).
  • A history of alcoholism, drug abuse, or drug addiction within the past 12 months.
  • Patients who have participated in any other trials involving an investigational product or device within 30 days of screening or longer as required by local regulations.
  • Patients receiving more than 1 background AED for their epilepsy. Patients receiving carbamazepine for their condition.
  • Patients who are allergic to levetiracetam or carbamazepine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894010

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United States, Maryland
Johns Hopkins Hospital, Adult Epilepsy Center
Baltimore, Maryland, United States, 21287
United States, New York
NYU Comprehensive Epilepsy Center
New York, New York, United States, 10016
Sponsors and Collaborators
The Epilepsy Study Consortium
The Epilepsy Research Foundation
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Principal Investigator: Jacqueline French, M.D. NYU Comprehensive Epilepsy Center
Additional Information:
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Responsible Party: The Epilepsy Study Consortium Identifier: NCT00894010    
Other Study ID Numbers: TESC-001
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Keywords provided by The Epilepsy Study Consortium:
Photosensitive epilepsy
Additional relevant MeSH terms:
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Epilepsy, Reflex
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers