Primary endpoint
RLS
Of the 20 participants, 14 (70%) successfully reduced their opioid dose by ≥ 20% with a CGI-I score of ≤ 5. Thus, the percentage of participants who met the primary endpoint exceeded the prespecified success criterion of 50%. The average attempted opioid dose reduction in step-down 1 was 32.7% for the 14 successful participants and 33.3% for the 6 unsuccessful participants. Of the 6 unsuccessful participants, one completed a 17% dose reduction, one completed a 21% dose reduction with CGI-I of 6, three withdrew during step-down 1 due to increased RLS symptoms, and one withdrew for personal reasons.