Juvmo (tavapadon)

The registry record for NCT02687542 gives Pfizer as sponsor, B7601003 as the sponsor study number, 2015-004912-39 as the EudraCT number, and A-ROSE as an alias study number. The actual study start date was 3 March 2016, and the actual primary completion and study completion dates were both 10 November 2017. The record lists 57 study locations in 6 countries: the United States (33 sites), France (6), Spain (6), Germany (5), Japan (5), and Canada (2). Results were first posted on 24 December 2018.

NCT02687542 was terminated on 25 September 2017 for insufficient efficacy after an interim analysis, with 108 of approximately 198 planned participants randomized, and no peer-reviewed publication of its results has been identified; results are available only from the ClinicalTrials.gov record and from the discussion in the publication of the linked early Parkinson's disease trial. Groups were unbalanced (44 participants in the 15 mg group and 13 to 23 in each other group), and 1 of 13 and 1 of 15 participants completed treatment in the 1 mg and 3 mg groups. The primary endpoint was analyzed in 87 participants with a Bayesian dose-response model. The registry cautions that week 15 results are affected by missing data and protocol changes after week 10. Doses were fixed at 1, 3, 7, or 15 mg once daily after a 3-week titration.