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Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy (Forest)

Primary Purpose

Epilepsy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring epilepsy, memory, cognition, memantine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients with temporal lobe epilepsy, aged 18-65
  2. Seizure frequency of less than three per month
  3. Stabilized treatment for epilepsy, including AEDs and vagus nerve stimulation
  4. Intelligence Quotient of >70
  5. Native English speaker (most of the neuropsychological/cognitive tests have yet to be translated and/or validated in non-English speaking populations. Thus, at this point we are limited to testing English speakers, only.)
  6. Able to count seizures accurately and maintain a seizure diary
  7. Recent AED levels performed within the last month within therapeutic range

Exclusion Criteria:

  1. Progressive neurologic disease
  2. Severe medical illness, including renal insufficiency
  3. Severe depression, bipolar disease or psychosis
  4. Pregnant or lactating women.

Sites / Locations

  • University of California, Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Memantine

Placebo

Arm Description

After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.

After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.

Outcomes

Primary Outcome Measures

Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2009
Last Updated
May 24, 2017
Sponsor
University of California, Davis
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00986115
Brief Title
Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
Acronym
Forest
Official Title
Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
our site was unable to enroll any qualified subjects
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
People with epilepsy often experience problems with their memories and other thinking skills that get worse over time. The investigators hope to learn more about whether a drug called memantine can help improve or stabilize (keep the same) memory and other thought processes in people with epilepsy by blocking a chemical that is released in the brain during seizures. The investigators also want to see if memantine changes the frequency (how often) people with epilepsy have seizures. Memantine is currently approved by the United States Food and Drug Administration (FDA) for treatment of patients with Alzheimer's disease.
Detailed Description
This is a double-blind, placebo-controlled trial of the effects of memantine in adult epilepsy patients. Patients will be assessed for neurocognitive outcomes, seizure frequency and side effects. After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue. The neuropsychological battery performed during baseline will be repeated at the end of the twelve month treatment period. No special procedures are required for this study, except the neuropsychological testing, which is not a routinely performed evaluation for adult epilepsy outpatients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, memory, cognition, memantine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine
Arm Type
Active Comparator
Arm Description
After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda, Axura
Intervention Description
After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
After a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. The treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. The dose escalation is 5 mg in PM for days 1-7, 5 mg twice daily for days 8-14, 5 mg in AM and 10 mg in PM for days 15-21 and 10 mg twice daily from day 22 and continue.
Primary Outcome Measure Information:
Title
Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with temporal lobe epilepsy, aged 18-65 Seizure frequency of less than three per month Stabilized treatment for epilepsy, including AEDs and vagus nerve stimulation Intelligence Quotient of >70 Native English speaker (most of the neuropsychological/cognitive tests have yet to be translated and/or validated in non-English speaking populations. Thus, at this point we are limited to testing English speakers, only.) Able to count seizures accurately and maintain a seizure diary Recent AED levels performed within the last month within therapeutic range Exclusion Criteria: Progressive neurologic disease Severe medical illness, including renal insufficiency Severe depression, bipolar disease or psychosis Pregnant or lactating women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rogawski, MD, PhD
Organizational Affiliation
University of California, Davis Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy

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