PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial.
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ABSTRACT: Background:PF-06649751 is a novel, oral, non-catechol-based, D1/D5 dopamine receptor partial agonist under investigation for the treatment of motor symptoms associated with Parkinson's disease. Methods:A 15-week, phase?II, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of flexible-dose PF-06649751 in subjects with early stage Parkinson's disease (ClinicalTrials.gov identifier: NCT02847650). Results:Enrollment was terminated early for reasons unrelated to the trial. Overall, 57 subjects received study medication (PF-06649751?=?29; placebo?=?28) and 47 completed the study (PF-06649751?=?25; placebo?=?22). Despite early termination, the study met its primary endpoint with the PF-06649751 group showing statistically significant improvement from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part?III score at week?15 compared with placebo. Mean (SE) change in MDS-UPDRS Part?III score was -9.0 (1.54) for PF-06649751 and -4.3 (1.65) for placebo. This corresponds to an improvement versus placebo of 4.8 for the PF-06649751 group (two-sided p?=?0.0407; 90% CI?=?1.0, 8.6). Statistically significant improvement in MDS-UPDRS-III score was also observed at all assessment time points prior to week 15. The safety profile of PF-06649751 was similar to that observed in prior studies, with the majority of adverse events (AEs) reported as mild or moderate. The most common AEs in the PF-06649751 group were nausea, headache, dry mouth, somnolence, and tremor. Conclusions:Once-daily dosing of oral PF-06649751 resulted in significant improvement of motor symptoms and was generally well tolerated in subjects with early stage Parkinson's disease.
SUBMITTER: Riesenberg R
PROVIDER: S-EPMC7066585 | biostudies-literature | 2020
REPOSITORIES: biostudies-literature
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