Cognitive Effects of Treatment of Interictal Discharges - NCT00916149-02114 (Clinical Trial 297076)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy297076.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Boston |
|
State:
|
|
MA |
| Zip Code: |
|
02114 |
| Conditions: |
|
Epilepsy |
| Purpose: |
|
The purpose of this study is to determine if levetiracetam (for patients with focal
seizures) or lamotrigine (for patients with generalized seizures) reduces the occurrence of
interictal discharges. The study investigates the possible correlation between reduction
of interictal discharges and improved cognitive performance.
|
| Study summary: |
|
Subjects newly diagnosed with seizures will be studied with electroencephalography (EEG) and
offered medication for prevention of recurrent seizures. Those with focal seizures will be
treated with levetiracetam, and those with generalized seizures will be treated with
lamotrigine. Subjects will undergo repeated EEG with concurrent cognitive testing before
and after initiation of treatment. The proposed study tests 3 hypotheses: 1. that treatment
with levetiracetam will reduce focal interictal epileptiform activity, 2. that treatment
with lamotrigine will reduce generalized interictal epileptiform activity, and 3. that the
extent of interictal epileptiform activity is inversely associated with performance on
neuropsychological batteries and computerized cognitive testing. Repeated
cognitive/neuropsychological testing obtained at steady state of the study drug and again
after approximately 2 months on the final dosage will serve to evaluate the timecourse of
potential cognitive benefits. |
| Criteria: |
|
Inclusion Criteria
- 18-55 years of age
- Normal IQ (≥ 80) as estimated by the Wechsler Test of Adult Reading (WTAR)
- Able to give consent
- Newly diagnosed focal or generalized epilepsy, based on clinical history and EEG
- The subject's treating physician is planning to prescribe levetiracetam for focal or
lamotrigine for generalized seizure prevention
- Untreated with antiepileptic medications at the time of enrollment
- Either symptomatic or idiopathic seizures.
Exclusion Criteria:
- Non-native English speaking and/or multilingual
- Frequent seizures, since seizures themselves impair cognitive function and present a
confounding variable. Subjects may have no more than one seizure or one cluster of
seizures per month, with a cluster of seizures including more than one seizure, but
between which the patient returns to baseline. The cluster may occur over no more
than two consecutive days in one month.
- The sentinel seizure(s) must not have occurred within 3 days of enrollment and
testing.
- Those with focal seizures who have evidence of renal disease (creatinine clearance
less than 80) will be excluded from participation, as levetiracetam is cleared by the
kidney.
- Those with focal seizures who have neutrophil counts <1000/uL will be excluded from
participation, as levetiracetam may lower white blood cell counts.
- Those with focal seizures and irritability or mood swings will not be eligible for
participation, as levetiracetam may exacerbate these symptoms. This will be
determined by self-report, information obtained from the referring physician and
medical record.
- Those with generalized seizures who have moderate to severe liver dysfunction
(Child-Pugh Grades B and C) will be excluded from participation, as lamotrigine is
cleared by the liver and the proposed dosing may not be tolerable in this population.
This will be determined by self-report, information obtained from the referring
physician, a comprehensive metabolic panel (routinely obtained in new-onset seizures)
and the medical record.
- Subjects who are pregnant will not be eligible to take part in the study, as
levetiracetam and lamotrigine are classified as Pregnancy Category C drugs and may
pose risk to the fetus. Women of childbearing potential will have a urine pregnancy
test prior to participation in the study. The urine pregnancy test will be repeated
at the final study visit. Subjects with epilepsy who are of childbearing potential
must use acceptable methods of birth control during the study, to be continued until
one month after discontinuation of the study drug. If a subject does become pregnant
during this time period, she must notify the investigators.
- Women who are breastfeeding may not participate in this study. Levetiracetam and
lamotrigine may pass into the breastmilk of nursing mothers, posing a risk to the
baby.
- Hypersensitivity to lamotrigine, levetiracetam or any components of these products |
|
|
|
| Study is available at: |
|
Massachusetts General Hospital
Boston, MA 02114
United States
Primary Contact:
Ashley M Kopec, B.S.
Email: akopec@partners.org
Phone: 617-643-4617 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|