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

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ClinicalTrials.gov Identifier: NCT00986115
Recruitment Status : Withdrawn (our site was unable to enroll any qualified subjects)
First Posted : September 29, 2009
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Memantine Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients With Epilepsy
Study Start Date : July 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients. [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986115


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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00986115     History of Changes
Other Study ID Numbers: 200816572
First Posted: September 29, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents