NCT03779672

Memantine for Epileptic Encephalopathy

Randomized Double-blind Placebo-controlled Trial of Memantine Hydrochloride for the Treatment of Childhood-onset Epileptic Encephalopathies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kenneth Myers, MD · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Epileptic Encephalopathy, Childhood-Onset

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-07
• Primary completion: 2021-11-08
• Completion: 2022-02-08
• First posted: 2018-12-19
• Last updated: 2022-03-11

Locations

1 site across 1 country: Canada