Photosensitivity Proof of Concept Trial
Primary Purpose
Photosensitive Epilepsy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carbamazepine 400mg
levetiracetam 1000mg
Sponsored by
About this trial
This is an interventional treatment trial for Photosensitive Epilepsy focused on measuring Photosensitive epilepsy, Photosensitivity, Seizures, Epilepsy
Eligibility 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.
Sites / Locations
- Johns Hopkins Hospital, Adult Epilepsy Center
- NYU Comprehensive Epilepsy Center
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00894010
First Posted
May 5, 2009
Last Updated
March 1, 2012
Sponsor
The Epilepsy Study Consortium
Collaborators
The Epilepsy Research Foundation, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00894010
Brief Title
Photosensitivity Proof of Concept Trial
Official Title
Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Epilepsy Study Consortium
Collaborators
The Epilepsy Research Foundation, GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photosensitive Epilepsy
Keywords
Photosensitive epilepsy, Photosensitivity, Seizures, Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carbamazepine 400mg
Other Intervention Name(s)
Tegretol
Intervention Type
Drug
Intervention Name(s)
levetiracetam 1000mg
Other Intervention Name(s)
Keppra
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline French, M.D.
Organizational Affiliation
NYU Comprehensive Epilepsy Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital, Adult Epilepsy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
NYU Comprehensive Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.epilepsyconsortium.org
Description
The Epilepsy Study Consortium
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Photosensitivity Proof of Concept Trial
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