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

This study has been withdrawn prior to enrollment.
(our site was unable to enroll any qualified subjects)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Michael A. Rogawski, MD, PhD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00986115
First received: September 25, 2009
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Epilepsy
Drug: Memantine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Memantine
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.
Drug: Memantine
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.
Other Names:
  • Namenda
  • Axura
Placebo Comparator: Placebo
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.
Drug: Placebo
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986115

Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Michael A. Rogawski, MD, PhD
Forest Laboratories
Investigators
Principal Investigator: Michael Rogawski, MD, PhD University of California, Davis Health System
  More Information

No publications provided

Responsible Party: Michael A. Rogawski, MD, PhD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00986115     History of Changes
Other Study ID Numbers: 200816572
Study First Received: September 25, 2009
Last Updated: October 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
epilepsy
memory
cognition
memantine

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 22, 2014