Photosensitivity Proof of Concept Trial

This study has been completed.
Sponsor:
Collaborators:
The Epilepsy Research Foundation
GlaxoSmithKline
Information provided by (Responsible Party):
The Epilepsy Study Consortium
ClinicalTrials.gov Identifier:
NCT00894010
First received: May 5, 2009
Last updated: March 1, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 ]

Enrollment: 6
Study Start Date: May 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: carbamazepine 400mg
    Other Name: Tegretol
    Drug: levetiracetam 1000mg
    Other Name: Keppra
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
GlaxoSmithKline
Investigators
Principal Investigator: Jacqueline French, M.D. NYU Comprehensive Epilepsy Center
  More Information

Additional Information:
No publications provided

Responsible Party: The Epilepsy Study Consortium
ClinicalTrials.gov Identifier: NCT00894010     History of Changes
Other Study ID Numbers: TESC-001
Study First Received: May 5, 2009
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014