Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction?

NACompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Epilepsy
Interventions
DRUG

Memantine

All subjects in the treatment group will be placed on memantine. The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The dosing will increase slowly, to minimize the risk of side effects. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the first phase of the study. At the conclusion of the first 13 weeks, subjects will discontinue the treatment (memantine or placebo) and enter the open label phase.

OTHER

Sugar Pill

In the control arm of the study, subjects will take one placebo sugar pill per day for one week, then increase to one tablet twice per day for the following 12 weeks. At the end of this phase of the study, subjects will enter the open-label phase (unblinded treatment with memantine).

DRUG

Memantine

Open label: When the blinded phase is complete (Weeks 1-13), all subjects will receive open-label treatment with memantine (Weeks 14-26). The dosage of memantine will begin at 5mg once per day (qday), and increase by 5mg every week. The titration will continue over a period of 3 weeks until a goal of 10mg bid is reached. The dosing will increase slowly, to minimize the risk of side effects. The subject will then remain on memantine at 10mg bid for 10 weeks, until the conclusion of the study. At the conclusion of the study, subjects will discontinue the treatment.

Trial Locations (3)

30322

Emory University, Atlanta

02114

Massachusetts General Hospital, Boston

02462

Newton-Wellesley Hospital, Newton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

lead

American Academy of Neurology

OTHER

NCT01054599 - Does Memantine Improve Verbal Memory Task Performance in Subjects With Partial Epilepsy and Memory Dysfunction? | Biotech Hunter | Biotech Hunter