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Cognitive Effects of Treatment of Interictal Discharges

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: levetiracetam (Drug); Lamotrigine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Daniel B Hoch, M.D., Ph.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Samantha R Donovan, B.S., Phone: 617-643-4617, Email: sdonovan@mclean.harvard.edu

Summary

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.

Clinical Details

Official title: Cognitive Effects of Treatment of Interictal Discharges

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Reduction of focal interictal discharges. The proposed study tests the hypothesis that treatment with levetiracetam will reduce focal interictal epileptiform activity.

Reduction of generalized interictal discharges. The proposed study tests the hypothesis that treatment with lamotrigine will reduce generalized interictal epileptiform activity.

The study will evaluate the hypothesis that reduction of focal and generalized interictal epileptiform activity is associated with improved performance on neuropsychological batteries and computerized cognitive testing.

Detailed description: Subjects 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- 18-65 years of age

- Normal IQ (≥ 80) as estimated by the Wechsler Test of Adult Reading (WTAR)

- Able to give consent

- The subject's treating physician is planning to prescribe levetiracetam for focal or

lamotrigine for generalized seizure prevention

- 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.

- 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

Locations and Contacts

Samantha R Donovan, B.S., Phone: 617-643-4617, Email: sdonovan@mclean.harvard.edu

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Daniel B Hoch, M.D., Ph.D., Principal Investigator
Additional Information

Related publications:

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Starting date: January 2007
Last updated: January 4, 2013

Page last updated: August 23, 2015

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