Status:
UNKNOWN
Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Focal Epilepsy
Generalized Epilepsy
Eligibility:
All Genders
12+ years
Brief Summary
Background: Epilepsy is a chronic neurological disease which affects approximately 70,000 patients in Hong Kong and 50 billion people worldwide. Among these patients one-third remained unresponsive t...
Detailed Description
Epilepsy is a chronic neurological disease which affects approximately 70,000 patients in Hong Kong and 50 billion people worldwide. Among these patients, one-third remained unresponsive to antiepilep...
Eligibility Criteria
Inclusion
- Subject aged 12 years or above
- Subject has a diagnosis of epilepsy with simple partial seizure and/or complex partial seizures
- Subjects who have a baseline seizure rate of more than 2 per month in the eight week period preceding the start of AMPA / NMDA receptor antagonist
- No seizure free period longer than 21 days during the eight week period before AMPA receptor antagonist was started
- Patients who already had neuropsychiatric inventory completed twice during the treatment period spanning at least 16 weeks.
Exclusion
- Subjects with idiopathic generalised epilepsy (for example, juvenile myoclonic epilepsy and absence epilepsy)
- Patients who only suffer from isolated auras
- Baseline creatinine clearance of less than 50ml/min
- Severe hepatic impairment with ALT three times the upper limits of normal
- Significant psychiatric conditions before the start of AMPA / NMDA receptor antagonist
- Progressive neurodegenerative conditions
- Active history of malignancy
- History of severe haematological conditions or serious blood dyscrasias
- Corrected QT interval more than 450 milli-second on ECG
- Substance abuse
- Pregnancy, breastfeeding
Key Trial Info
Start Date :
July 23 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03457961
Start Date
July 23 2016
End Date
July 1 2021
Last Update
August 27 2020
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong, 0000