Status:
COMPLETED
Memantine for Epileptic Encephalopathy
Lead Sponsor:
Kenneth Myers, MD
Conditions:
Epileptic Encephalopathy, Childhood-Onset
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03779672
Start Date
February 7 2019
End Date
February 8 2022
Last Update
March 11 2022
Active Locations (1)
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1
Children Hospital - MUHC
Montreal, Quebec, Canada, H4A 3J1