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Memantine for Epileptic Encephalopathy

NCT03779672 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-11

No results posted yet for this study

Summary

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.

Conditions

  • Epileptic Encephalopathy, Childhood-Onset

Interventions

DRUG

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

Sponsors & Collaborators

  • Kenneth Myers, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2021-11-08
Completion
2022-02-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03779672 on ClinicalTrials.gov