Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-01-15

Brief Summary

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Evaluate the efficacy of memantine on improving the cognitive impairment in patient with epilepsy

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Detailed Description

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Epilepsy is a complex disorder, which involves much more than seizures, encompassing a range of associated comorbid health conditions that can have significant health and quality-of-life implications. Of these comorbidities, cognitive impairment is one of the most common and distressing aspects of epilepsy.

Excito-toxicity, mediated by glutamate acting on N-methyl-D-aspartate (NMDA) receptors in the hippocampus, can cause memory dysfunction in epilepsy .

Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor . It also has antioxidant property and increases production of brain derived neurotropic factor (BDNF)

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

100 patients divided into two groups each group 50patients

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Memantine hydrochloride group

included 50 patients who received memantine

Group Type ACTIVE_COMPARATOR

Memantine Hydrochloride

Intervention Type DRUG

Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

Placebo group

included 50 patients who received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

Interventions

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Memantine Hydrochloride

Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

Intervention Type DRUG

Placebo

Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.

Intervention Type DRUG

Other Intervention Names

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Memantine

Eligibility Criteria

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Inclusion Criteria

* Patients with idiopathic epilepsy.
* Normal brain imaging (CT brain).
* Patients on anti epileptic drugs more than 6 months.
* No more than two fits per month.
* Score of Mini mental state examination (10-24), mild and moderate cognitive impairment.
* No other medical disorders.

Exclusion Criteria

* Progressive neurological diseases.
* Abnormal brain imaging (CT brain).
* More than two fits per month.
* Patients with severe cognitive impairment, score of MMSE less than10.
* Patients with severe medical disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No