Designing clinical trials to assess antiepileptic drugs as monotherapy: Difficulties and solutions

CNS Drugs

Volumn 22, Issue 11, 2008, Pages 917-938

  Perucca, Emilio ^a  

^a UNIVERSITY OF PAVIA   (Italy)

Author keywords

Antiepileptic drugs, therapeutic use; Clinical trial design; Epilepsy, treatment; Ethics; European Medicines Agency; Food and Drug Administration; Regulatory process

Indexed keywords

ANTICONVULSIVE AGENT; CARBAMAZEPINE; DIAZEPAM; ETIRACETAM; FELBAMATE; GABAPENTIN; GANAXOLONE; LAMOTRIGINE; LOSIGAMONE; OXCARBAZEPINE; PLACEBO; PREGABALIN; REMACEMIDE; RUFINAMIDE; TIAGABINE; TOPIRAMATE; VALPROIC ACID;

CLINICAL TRIAL; COMPARATIVE STUDY; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG FORMULATION; DRUG MEGADOSE; EPILEPSY; EUROPE; FOOD AND DRUG ADMINISTRATION; HUMAN; LOW DRUG DOSE; METHODOLOGY; MONOTHERAPY; PRIORITY JOURNAL; PROGNOSIS; REVIEW; RISK BENEFIT ANALYSIS; SEIZURE; SENSITIVITY ANALYSIS; UNITED STATES;

ANTICONVULSANTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EPILEPSY; EUROPEAN UNION; HUMANS; RESEARCH DESIGN; TREATMENT OUTCOME; UNITED STATES;

EID: 53549106359     PISSN: 11727047     EISSN: None     Source Type: Journal    
DOI: 10.2165/00023210-200822110-00003     Document Type: Review

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