Advantages and disadvantages of various trial designs, including placebo-controlled monotherapy or add-on trials, noninferiority studies, and withdrawal trials are also discussed.
Perampanel is no exception and we were only able to identify add-on trials.
A persistent concern has been whether patients enrolled in these add-on trials had previously responded to background therapy.
Add-on trials to established antiepileptic drugs in patients with drug resistant epilepsy has been the primary approach for many years in human medicine.
Thus, if seizure freedom is not achieved time to the 2nd or nth seizure was considered as an alternative outcome parameter for add-on trials in patients with chronic refractory epilepsy [ 1, 65].
Because co-administered drugs are subject to drug interactions, add-on trials of antiepileptic drugs do not necessarily address the utility of a new drug as monotherapy or its use in patients with newly diagnosed epilepsy [ 25].
Several add-on trials have demonstrated significant pain relief and improvement in QOL following treatment with controlled-release oxycodone, a pure μ-agonist, in patients with painful DSPN whose pain was not adequately controlled on standard treatment with antidepressants and anticonvulsants.
Immediate steps that could increase the pool of potential subjects for such add-on trials is to include patients who are being treated with metformin and/or insulin and/or any other antidiabetic drug of a different class and to expand the age range of eligible subjects from 10 17 years to 10 21 years.
The very different results obtained from the controlled monotherapy trials of topiramate in mania and the open add-on trials summarised in the Background indicate that topiramate should not be prescribed as monotherapy in bipolar disorders as it has no acute antimanic effect.
The first, an open-label add-on trial, was conducted in 20 subjects aged 13 35 years, with one dropping out as a result of adverse effects.
Ganaxolone was safe and effective in treating this group of refractory infantile spasms patients in an open-label, add-on trial.
