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

Epilepsy Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00986115
• Other study ID #: 200816572
• Status: Withdrawn
• Phase: N/A
• First received: September 25, 2009
• Last updated: May 24, 2017
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in neuropsychological test scores over time between memantine and placebo treated groups of temporal lobe epilepsy patients.		5 years