Photosensitive EpilepsyPhase 2NCT00894010
Photosensitivity Proof of Concept Trial
A Phase 2 study testing carbamazepine 400mg and levetiracetam 1000mg in people with Photosensitive Epilepsy, run by The Epilepsy Study Consortium at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Photosensitive Epilepsy
- What is being tested?
- carbamazepine 400mg and levetiracetam 1000mg
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital, Adult Epilepsy Center
Baltimore, Maryland, 21287
NYU Comprehensive Epilepsy Center
New York, New York, 10016
About this study
Official title: Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial
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
- Being tested
- carbamazepine 400mg, levetiracetam 1000mg
- Keywords
- Photosensitive epilepsy, Photosensitivity, Seizures, Epilepsy
- Medical subject headings
- Epilepsy, Reflex, Photosensitivity Disorders, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbamazepine 400mgDrug
Also called Tegretol
levetiracetam 1000mgDrug
Also called Keppra
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the completion of each cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photosensitive EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Epilepsy Study Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- The Epilepsy Research Foundation, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Jacqueline French, M.D., Principal investigator, NYU Comprehensive Epilepsy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894010
- Sponsor's protocol ID
- TESC-001
- Status last verified
- Mar 2012
- First submitted
- 5 May 2009
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Marketed AEDs in the Human Photosensitivity Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT00894010
- Acronym / sponsor ID
- TESC-001
- Conditions
- Photosensitive Epilepsy
- Keywords
- Photosensitive epilepsy, Photosensitivity, Seizures, Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Epilepsy Study ConsortiumUniversity, hospital or other
- Collaborators
- The Epilepsy Research Foundation, GlaxoSmithKline
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbamazepine 400mgAlso: Tegretol | Drug | – |
| levetiracetam 1000mgAlso: Keppra | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- The Epilepsy Study ConsortiumLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline French, M.D. principal investigator
NYU Comprehensive Epilepsy Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carbamazepine 400mg and levetiracetam 1000mg in people with Photosensitive Epilepsy, run by The Epilepsy Study Consortium at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.