NCT04417543

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 2, 2020

Last Update Submit

June 3, 2020

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

  • Memory Assessment Scale (MAS)

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

    1.5years

  • Wechsler Adult Intelligence Scale (WAIS)

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

    1.5years

  • 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.

    1.5years

Study Arms (2)

Memantine hydrochloride group

ACTIVE COMPARATOR

included 50 patients who received memantine

Drug: Memantine Hydrochloride

Placebo group

PLACEBO COMPARATOR

included 50 patients who received placebo

Drug: Placebo

Interventions

Memantine HydrochlorideDRUG

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.

Also known as: Memantine
Memantine hydrochloride group
PlaceboDRUG

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

Placebo group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salma Mohmed Fahmy

Asyut, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 21304484BACKGROUND

  • 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.

    PMID: 21964564BACKGROUND

  • 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.

    PMID: 24365760BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Memantine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 100 patients divided into two groups each group 50patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 4, 2020

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

January 15, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

EG(1)