In add-on studies, it is recommended that patients completing double-blind assessment be offered indefinite open-label treatment, and that safety data be collected prospectively.
The recent comparative study between carbamazepine and remacemide, however, suggests that subtle pharmacokinetic/pharmacodynamic interactions between established and new AEDs can indicate efficacy in add-on studies that does not necessarily transfer to monotherapy.
The majority of clinical trials of antiepileptic drugs (AEDs) fall into two main groups: (i) phase II and early phase III add-on studies in people with drug-resistant, chronic epilepsy, and (ii) late phase III parallel-group monotherapy studies in newly diagnosed patients.
The sham response is negatively associated with refractoriness and positively associated with rTMS add-on studies; whereas sham method utilized, age and gender are not associated with a greater sham response.
AF was Principal Investigator in the MRC Trial and advised on the add-on studies.
The potential for drug drug interactions between luseogliflozin and pioglitazone or voglibose was examined in open-label, add-on studies.
Previously, we have suggested that "add-on studies" is scientifically more accurate than "placebo-controlled" (Greenstein et al., 2014).
The remaining two trials were randomized, double-blind, placebo-controlled, add-on studies where colesevelam 3.8 g versus placebo had been added to patients treated with ezetimibe.
However, although other studies permitted the use of other medications, no homogeneous active-controlled GH add-on studies have been performed to date in this population.
ANOVA was also used in the add-on studies using treatment as a fixed effect and subject as a random effect.
The study results represent the incremental benefit of adding biologic therapy to optimum non-biologic therapy, and are in accord with recent add-on studies.
