Introduction to Randomised Withdrawal
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Methods COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP).
To overcome the dilemma between ethically problematic trials and lack of evidence, the full repertoire of clinical trial designs (eg, observational, randomisedregistry trials as well as randomised withdrawal and randomised clinical trials) is needed to adequately address the different patient groups and different research questions (quality of life vs longterm cardiovascular outcomes).
Methods and analysis The PATCH trial is a double-blind, enriched enrolment with randomised withdrawal, vehicle-controlled trial, aiming to explore the effects and safety of LMP in patients with TN.
We suggest that an enriched enrolment with randomised withdrawal design may overcome some of these methodological shortcomings.
At Wk41, the number of patients on CAN was limited (crFMF n=9, HIDS/MKD n=6 and TRAPS n=4) due to the design of the trial (randomised withdrawal part).
A 2-week, placebo-controlled, randomised withdrawal (RW) phase was conducted after 6 months.