Overview
Memantine for Epileptic Encephalopathy
Status:
Recruiting
Recruiting
Trial end date:
2022-05-31
2022-05-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kenneth Myers, MDTreatments:
Memantine
Criteria
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