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Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Memantine Hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Salma Mohmed Fahmy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Memantine hydrochloride group

Placebo group

Arm Description

included 50 patients who received memantine

included 50 patients who received placebo

Outcomes

Primary Outcome Measures

Memory Assessment Scale (MAS)

This comprehensive battery assesses short-term, verbal and visual memory functioning.

Wechsler Adult Intelligence Scale (WAIS)

Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.

Brief Visuospatial Memory Test-Revised (BVMT-R)

The current revised version of the BVMT, a visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials.

Secondary Outcome Measures

Full Information

NCT ID

NCT04417543

First Posted

June 2, 2020

Last Updated

June 3, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04417543

Brief Title

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Official Title

Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

October 1, 2019 (Actual)

Study Completion Date

January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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

Detailed Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

100 patients divided into two groups each group 50patients

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Memantine hydrochloride group

Arm Type

Active Comparator

Arm Description

included 50 patients who received memantine

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

included 50 patients who received placebo

Intervention Type

Drug

Intervention Name(s)

Memantine Hydrochloride

Other Intervention Name(s)

Memantine

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Memory Assessment Scale (MAS)

Description

This comprehensive battery assesses short-term, verbal and visual memory functioning.

Time Frame

1.5years

Title

Wechsler Adult Intelligence Scale (WAIS)

Description

Intelligence quotient (IQ) tests are the primary clinical instruments used to measure adult and adolescent intellience.

Time Frame

1.5years

Title

Brief Visuospatial Memory Test-Revised (BVMT-R)

Description

The current revised version of the BVMT, a visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials.

Time Frame

1.5years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Salma Mohmed Fahmy

City

Assiut

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

21304484

Citation

Bell B, Lin JJ, Seidenberg M, Hermann B. The neurobiology of cognitive disorders in temporal lobe epilepsy. Nat Rev Neurol. 2011 Mar;7(3):154-64. doi: 10.1038/nrneurol.2011.3. Epub 2011 Feb 8.

Results Reference

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PubMed Identifier

21964564

Citation

Aggleton JP. Multiple anatomical systems embedded within the primate medial temporal lobe: implications for hippocampal function. Neurosci Biobehav Rev. 2012 Aug;36(7):1579-96. doi: 10.1016/j.neubiorev.2011.09.005. Epub 2011 Sep 24.

Results Reference

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PubMed Identifier

24365760

Citation

Alvarez PS, Simao F, Hemb M, Xavier LL, Nunes ML. Effects of undernourishment, recurrent seizures and enriched environment during early life in hippocampal morphology. Int J Dev Neurosci. 2014 Apr;33:81-7. doi: 10.1016/j.ijdevneu.2013.12.004. Epub 2013 Dec 21.

Results Reference

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Effect of Memantine on Cognitive Impairment in Patients With Epilepsy

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