PMID- 32201505
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220413
IS  - 1756-2856 (Print)
IS  - 1756-2864 (Electronic)
IS  - 1756-2856 (Linking)
VI  - 13
DP  - 2020
TI  - PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, 
      placebo-controlled trial.
PG  - 1756286420911296
LID - 10.1177/1756286420911296 [doi]
LID - 1756286420911296
AB  - 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.
CI  - (c) The Author(s), 2020.
FAU - Riesenberg, Robert
AU  - Riesenberg R
AD  - Atlanta Center for Medical Research, Atlanta, GA, USA.
FAU - Werth, John
AU  - Werth J
AD  - Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA.
FAU - Zhang, Yao
AU  - Zhang Y
AD  - Pfizer Inc., Cambridge, MA, USA.
FAU - Duvvuri, Sridhar
AU  - Duvvuri S
AD  - Pfizer Inc., Cambridge, MA, USA.
FAU - Gray, David
AU  - Gray D
AD  - Pfizer Inc., Cambridge, MA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02847650
PT  - Journal Article
DEP - 20200306
PL  - England
TA  - Ther Adv Neurol Disord
JT  - Therapeutic advances in neurological disorders
JID - 101480242
PMC - PMC7066585
OTO - NOTNLM
OT  - D1/D5 receptor
OT  - PF-06649751
OT  - Parkinson's disease
OT  - partial agonist
OT  - phase II clinical trial
COIS- Conflict of interest statement: JW and YZ are full-time employees of, and own 
      stock or stock options, in Pfizer Inc. DG and SD were full-time employees of 
      Pfizer Inc. at the time the study was conducted, and own stock in Pfizer Inc. DG 
      is named on the patent for PF-06649751 (though all rights are assigned to Pfizer 
      Inc). RR has no potential conflicts to disclose. Medical writing support provided 
      by Matt Soulsby of Engage Scientific was funded by Pfizer. RR reports no 
      financial relationships with commercial interests. JW, and YZ have received 
      salary as full-time employees of Pfizer Inc. and own stock in Pfizer Inc. SD and 
      DG have received salary as full-time employees of Pfizer Inc., and subsequently 
      Cerevel Therapeutics, and own stock in Pfizer Inc.
EDAT- 2020/03/24 06:00
MHDA- 2020/03/24 06:01
PMCR- 2020/03/06
CRDT- 2020/03/24 06:00
PHST- 2019/07/02 00:00 [received]
PHST- 2019/12/02 00:00 [accepted]
PHST- 2020/03/24 06:00 [entrez]
PHST- 2020/03/24 06:00 [pubmed]
PHST- 2020/03/24 06:01 [medline]
PHST- 2020/03/06 00:00 [pmc-release]
AID - 10.1177_1756286420911296 [pii]
AID - 10.1177/1756286420911296 [doi]
PST - epublish
SO  - Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 
      10.1177/1756286420911296. eCollection 2020.