A feasibility study for a trial investigating thetreatment of sarcoidosis-associated fatigue withmethylphenidate

Objectives - The research objective was to determine the feasibility of performing an appropriately-powered study investigating the use of methylphenidate for sarcoidosis-associated fatigue. Methods - The Fatigue and Sarcoidosis – Treatment with Methylphendiate (FaSTMP) feasibility study was undertaken to compare methylphenidate with an identical placebo in a double-blind, randomised, parallel-arm study. Participants had the opportunity to discuss their perspectives on the study in post-trial focus groups. Alongside FaST-MP, further work was undertaken to determine future study design. Activity monitors were piloted to determine the preferred device in patients with sarcoidosis. Quality of life measures were compared using data from a cohort of patients with sarcoidosis to understand the relationship between clinical outcomes. Findings – Participant recruitment to the FaST-MP study was lower than expected (22 participants) but retention was high (100%) and the medication appeared welltolerated and safe. No statistical difference in change in fatigue scores was seen between the methylphenidate and placebo arms, although both groups showed improvement from baseline fatigue scores. Participants reported a positive experience of the trial from focus group discussion but raised concerns relating to the fatigue outcomes used and the frequency with which fatigue was measured. Comparison of quality of life questionnaires identified differences between two commonly used measures which may influence questionnaire choice in future studies investigating sarcoidosis-associated fatigue. Conclusion - Designing a full phase III study to investigate the clinical efficacy of methylphenidate for sarcoidosis-associated fatigue appears feasible, although future study design must consider how to best reflect “usual care”, as well as the optimal outcome measures within such a study.