Cognitive Effects of Treatment of Interictal Discharges
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cognitive Effects of Treatment of Interictal Discharges|
- Reduction of focal interictal discharges. The proposed study tests the hypothesis that treatment with levetiracetam will reduce focal interictal epileptiform activity. [ Time Frame: 1, 4, and 11 weeks ] [ Designated as safety issue: No ]
- Reduction of generalized interictal discharges. The proposed study tests the hypothesis that treatment with lamotrigine will reduce generalized interictal epileptiform activity. [ Time Frame: 1, 10, and 15 weeks ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 1, 4, and 11 weeks (Arm 1) or 1, 10, and 15 weeks (Arm 2) ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Levetiracetam
12 individuals with epilepsy, 6 of whom experience infrequent focal epileptiform discharges and 6 of whom experience frequent focal discharges. These individuals will be treated with levetiracetam (LEV). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LEV on discharge frequency, discharge duration, and cognitive task performance.
The dosage of levetiracetam will begin at 500mg twice per day (bid) for the first 4 days, and increase by 500mg every 5 days thereafter until a goal of 1500mg bid is reached. The subject will then remain on levetiracetam at 1500mg bid for 8 weeks, until the conclusion of the study. Medication will be supplied in 500mg tablets, to be taken orally.
Other Name: Keppra
Active Comparator: Lamotrigine
12 individuals with epilepsy, 6 of whom experience infrequent generalized discharges and 6 of whom experience frequent generalized discharges. These individuals will be treated with lamotrigine (LMT). They will complete repeated EEG/cognitive testing pre- and post-treatment to assess the effects of LMT on discharge frequency, discharge duration, and cognitive task performance.
The drug will be supplied in 25, 100 and 150mg tablets, to be taken orally per the titration schedule below:
The regimen will begin at 25mg once per day for the first two weeks, and increase to 50mg once per day during weeks 3 and 4. In week 5, the subject will take 50mg twice per day (bid). The dosage will increase to 50mg in the morning and 100mg at night during week 6. During week 7 the subject will take 100mg bid. During week 8, the subject will take 100mg in the morning and 150mg at night. At week 9, the subject will reach the target dose of 150mg bid. The subject will then remain on lamotrigine at 150mg bid for 7 weeks, until the conclusion of the study.
Other Name: Lamictal
No Intervention: No treatment
15 healthy subjects, not receiving anticonvulsant medication, will undergo repeated EEG/cognitive testing as a control.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916149
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Daniel B Hoch, M.D., Ph.D.||Massachusetts General Hospital|