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The design of most add-on registration trials for anti epileptic drugs (AEDs) usually results in a calculated compromise regarding size, scope, cost, and duration. Appropriate trial duration incorporates issues such as efficacy, safety, and regulatory constraints and is dependent on sample size, titration usage, time to onset, and magnitude of treatment effect. Two phases are usually evaluated in these trials: baseline and treatment. Typical duration for add-on epilepsy registration trials range from 4 to 12 weeks of baseline evaluation followed by 12 to 18 weeks of double-blind treatment. Trials with shorter baseline and/or shorter double-blind periods would likely be less costly, more timely, and result in improved enrollment and retention rates. Data from large dose-response trial of 3 AEDs were retrospectively analyzed previously (Sahlroot and Pledger, 1998) to examine the effect of trial duration on the primary efficacy parameter. 2. Methods |
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