Open-label treatment

Following the study period, all patients (including those who had received placebo) will have the option of monitored open-label treatment with modafinil for a period of six additional months. The last visit of the controlled trial (study visit #3) will be the first visit for this open-label trial.

Treatment during the open-label trial will begin at the dose used during the study phase for those who had been randomized to modafinil and at 100 mg per day for those who had received placebo. Dose titration will be allowed at a weekly basis (100 mg per week) to a maximum daily dose of 400 mg per day. The nurse will monitor the patients with at least one telephone call weekly during this extended phase. Patients will be required to make study visits every two months. The questionnaire packet used during the controlled phase of the study will be administered at each visit during this phase.

Discussion: There are considerable advantages to the linkage of an open-label extension trial to a controlled study. It can provide information about the durability of the effects and the safety of the treatment on prolonged exposure. Because treatment mimics clinical practice, the extension phase can help assess the overall utility of therapy to the patient in a way that the more intensive exposure during the controlled trial cannot. Finally, it is likely that access to a long treatment period after the study enhances recruitment. Open-label follow-on studies can be included in the protocol for the controlled study, as it is in this example, or be offered as a separate protocol.