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

NCT00986115 | Withdrawn DMC

• 1 other identifier: 200816572
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; memory; cognition; memantine

Outcome Measures

Primary Outcomes (1)

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

  5 years

Study Arms (2)

Memantine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Memantine DRUG

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.

Also known as: Namenda, Axura

Memantine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Progressive neurologic disease
• Severe medical illness, including renal insufficiency
• Severe depression, bipolar disease or psychosis
• Pregnant or lactating women.

Sponsors & Collaborators

• University of California, Davis: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michael Rogawski, MD, PhD

  University of California, Davis Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 29, 2009
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)