Memantine for Epileptic Encephalopathy

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-07

Study Completion Date

2022-02-08

Brief Summary

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This study will evaluate the potential benefit of memantine hydrochloride as treatment for children with epileptic encephalopathy using a double-blind placebo-controlled cross-over design.

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Detailed Description

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Memantine, a drug approved for Alzheimer's dementia, exerts its therapeutic effect through its action as a low to moderate affinity non-competitive (open channel) N-methyl-D-aspartate receptor (NMDA-R) antagonist, which binds preferentially to the NMDA receptor-operated cation channels. It blocks the effects of persistently elevated levels of glutamate that may lead to neuronal dysfunction. Memantine may also have anti-inflammatory effects. Memantine has been used off-label in children and adolescents with autism spectrum disorder, to improve the cognitive impairment.

Epileptic encephalopathy, as well as other forms of epilepsy, may occur as a result of multiple etiologies, including genetic and inflammatory pathologies. Ion channels were long considered to be implicated in genetic epilepsy. Indeed one of the many possible causes of epilepsy is NMDA receptor dysfunction.

In the present study, the investigators plan to investigate the potential benefit of memantine as a treatment for epileptic encephalopathy. A double-blind placebo-controlled cross-over design will be used, with participants receiving 6 weeks of memantine and 6 weeks of placebo, with a 2-week washout period in between.

Conditions

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Epileptic Encephalopathy, Childhood-Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Monocentric, Off-Label Use, Randomized, crossover, Double-blinded Placebo vs Memantine.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded Placebo vs Memantine

Study Groups

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Memantine Hydrochloride 10 mg Placebo

Blue colour capsules, for oral administration, containing 5 mg of active memantine or matching placebo for oral administration.

Dose regimen:

Memantine Hydrochloride

* Week #1: 5 mg id (am), 1 caps
* Week #2: 5 mg bid (am and pm), 2 caps
* Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps

Washout (Weeks #7-8)

Placebo

* Week #9: id (am), 1 caps
* Week #10: bid (am and pm), 2 caps
* Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps

Group Type ACTIVE_COMPARATOR

Memantine Hydrochloride 10 mg

Intervention Type DRUG

* Week #1: 5 mg id (am), 1 caps
* Week #2: 5 mg bid (am and pm), 2 caps
* Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps
* Weeks #7-8: Washout

Placebo

* Week #9: id (am), 1 caps
* Week #10: bid (am and pm), 2 caps
* Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps

OR Placebo

* Week #1: id (am), 1 caps
* Week #2: bid (am and pm), 2 caps
* Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps
* Weeks #7-8: Washout

Memantine

* Week #9: 5 mg id (am), 1 caps
* Week #10: 5 mg bid (am and pm), 2 caps
* Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps

Placebo Memantine Hydrochloride 10 mg

Placebo

* Week #1: id (am), 1 caps
* Week #2: bid (am and pm), 2 caps
* Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps

Washout (Weeks #7-8) Memantine Hydrochloride

* Week #9: 5 mg id (am), 1 caps
* Week #10: 5 mg bid (am and pm), 2 caps
* Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps

Group Type PLACEBO_COMPARATOR

Memantine Hydrochloride 10 mg

Intervention Type DRUG

* Week #1: 5 mg id (am), 1 caps
* Week #2: 5 mg bid (am and pm), 2 caps
* Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps
* Weeks #7-8: Washout

Placebo

* Week #9: id (am), 1 caps
* Week #10: bid (am and pm), 2 caps
* Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps

OR Placebo

* Week #1: id (am), 1 caps
* Week #2: bid (am and pm), 2 caps
* Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps
* Weeks #7-8: Washout

Memantine

* Week #9: 5 mg id (am), 1 caps
* Week #10: 5 mg bid (am and pm), 2 caps
* Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps

Interventions

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Memantine Hydrochloride 10 mg

* Week #1: 5 mg id (am), 1 caps
* Week #2: 5 mg bid (am and pm), 2 caps
* Weeks #3-6: 5 mg am \& 2x 5 mg pm, 3 caps
* Weeks #7-8: Washout

Placebo

* Week #9: id (am), 1 caps
* Week #10: bid (am and pm), 2 caps
* Weeks #11-14: 1 caps am \& 2 caps pm, 3 caps

OR Placebo

* Week #1: id (am), 1 caps
* Week #2: bid (am and pm), 2 caps
* Weeks #3-6: 1 caps am \& 2 caps pm, 3 caps
* Weeks #7-8: Washout

Memantine

* Week #9: 5 mg id (am), 1 caps
* Week #10: 5 mg bid (am and pm), 2 caps
* Weeks #11-14: 5 mg am \& 2x 5 mg pm, 3 caps

Intervention Type DRUG

Other Intervention Names

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PrSANDOZ MEMANTINE FCT10 mg Drug Identification Number (DIN) 02375532

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained
* Age 6-18 years (Weight ≥ 20 kg)
* Clinical diagnosis of epileptic encephalopathy

* Subject with epilepsy and developmental impairment;
* Epileptic activity itself contributes to severe cognitive and behavioural impairments
* Patients will typically have already have trialed at least two standard therapies
* Females of childbearing age:
* Negative urinary pregnancy test at screening
* Agree to use effective contraception for the duration of the study

Exclusion Criteria

* Inability of a parent or legal guardian to give informed consent for any reason.
* Known hypersensitivity to memantine hydrochloride
* Taking concomitant Amantadine, Ketamine or Dextromethorphan, Cimetidine, Ranitidine, Procainamide, Quinidine, Quinine, Hydrochlorothiazide, Anticholinergics, L-dopa, Anticoagulant,
* Any degree of renal impairment

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No