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Photosensitivity Proof of Concept Trial
This study is currently recruiting participants.
Verified by The Epilepsy Study Consortium, July 2009
First Received: May 5, 2009   Last Updated: July 7, 2009   History of Changes
Sponsor: The Epilepsy Study Consortium
Collaborators: The Epilepsy Research Foundation
GlaxoSmithKline
Information provided by: The Epilepsy Study Consortium
ClinicalTrials.gov Identifier: NCT00894010
  Purpose

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 Intervention Phase
Photosensitive Epilepsy
Drug: carbamazepine 400mg
Drug: levetiracetam 1000mg
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title: Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial

Resource links provided by NLM:


Further study details as provided by The Epilepsy Study Consortium:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: May 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894010

Locations
United States, Maryland
Johns Hopkins Hospital, Adult Epilepsy Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Pamela Coe     410-502-5570     pcoe@jhmi.edu    
Principal Investigator: Gregory Krauss, M.D.            
United States, New York
NYU Comprehensive Epilepsy Center Recruiting
New York, New York, United States, 10016
Contact: Bree Vogelsong     646-558-0845     vogelsong.nyumc@gmail.com    
Principal Investigator: Jacqueline French, M.D.            
Sponsors and Collaborators
The Epilepsy Study Consortium
The Epilepsy Research Foundation
GlaxoSmithKline
Investigators
Principal Investigator: Jacqueline French, M.D. NYU Comprehensive Epilepsy Center
  More Information

Additional Information:
No publications provided

Responsible Party: NYU Comprehensive Epilepsy Center & The Epilepsy Study Consortium ( Jacqueline French, MD )
Study ID Numbers: TESC-001
Study First Received: May 5, 2009
Last Updated: July 7, 2009
ClinicalTrials.gov Identifier: NCT00894010     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by The Epilepsy Study Consortium:
Photosensitive epilepsy
Photosensitivity
Seizures
Epilepsy

Additional relevant MeSH terms:
Epilepsy, Reflex
Nootropic Agents
Tranquilizing Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Central Nervous System Diseases
Antimanic Agents
Brain Diseases
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Carbamazepine
Epilepsy
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Piracetam
Etiracetam
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010