PMID- 28370340
OWN - NLM
STAT- MEDLINE
DCOM- 20180206
LR  - 20181010
IS  - 1531-8257 (Electronic)
IS  - 0885-3185 (Linking)
VI  - 32
IP  - 5
DP  - 2017 May
TI  - A randomized trial of a low-dose Rasagiline and Pramipexole combination (P2B001) 
      in early Parkinson's disease.
PG  - 783-789
LID - 10.1002/mds.26941 [doi]
AB  - BACKGROUND: Rasagiline and pramipexole act to improve striatal dopaminergic
      transmission in PD via distinct and potentially synergistic mechanisms. We
      performed a placebo-controlled study to determine whether 2 doses of a novel
      slow-release, low-dose combination of rasagiline and pramipexole (P2B001) are
      effective and have a good safety profile in patients with early untreated PD.
      METHODS: Previously untreated patients with early PD were randomized (1:1:1) to
      once-daily treatment with P2B001 (0.3 mg pramipexole/0.75 mg rasagiline), P2B001 
      (0.6 mg pramipexole/0.75 mg rasagiline) or placebo in a 12-week multicenter
      double-blind, placebo-controlled trial. The primary endpoint was the change from 
      baseline to final visit in Total-UPDRS score versus placebo. Secondary measures
      included responder analyses of patients achieving >/=4 UPDRS point reduction, and
      changes in Parkinson Disease Quality of Life Scale-39 and UPDRS activities of
      daily living and motor scores. RESULTS: A total of 149 participants were
      randomized and 136 (91.3%) completed the study. Adjusted mean change from
      baseline to final visit versus placebo in Total-UPDRS score was -4.67 +/- 1.28
      points for the P2B001 0.6/0.75 mg group (P = .0004) and -3.84 +/- 1.25 points for
      the 0.3/0.75 mg group (P = .003). Significant benefits were also observed for
      both doses in the responder analysis (P = .0002 and P = .0001), Parkinson Disease
      Quality of Life Scale-39 scores (P = .05 and P = .01), and the UPDRS motor (P =
      .02 and P = .006) and activities of daily living (P = .005 and P = .0004)
      subscores. Adverse events of P2B001 were comparable to placebo apart from
      transient nausea and somnolence, which were more common with P2B001 treatment.
      CONCLUSIONS: P2B001 offers a promising treatment option for patients with early
      PD with good clinical efficacy and a low risk of adverse events. (c) 2017
      International Parkinson and Movement Disorder Society.
CI  - (c) 2017 International Parkinson and Movement Disorder Society.
FAU - Olanow, C Warren
AU  - Olanow CW
AD  - Clintrex LLC, Rye, New York, USA.
AD  - Mount Sinai School of Medicine, New York, New York, USA.
FAU - Kieburtz, Karl
AU  - Kieburtz K
AD  - Clintrex LLC, Rye, New York, USA.
AD  - University of Rochester School of Medicine, Rochester, New York, USA.
FAU - Leinonen, Mika
AU  - Leinonen M
AD  - Clintrex LLC, Rye, New York, USA.
AD  - 4Pharma AB, Stockholm, Sweden.
FAU - Elmer, Lawrence
AU  - Elmer L
AD  - Gardner-McMaster Parkinson Center, University of Toledo, Toledo, Ohio, USA.
FAU - Giladi, Nir
AU  - Giladi N
AD  - Parkinson's Disease and Movement Disorders Center, National Parkinson Foundation 
      (NPF) Center of Excellence, Neurological Institute, Tel-Aviv Medical Center,
      Sackler School of Medicine, Sagol School of Neuroscience, Tel Aviv University,
      Tel Aviv, Israel.
FAU - Hauser, Robert A
AU  - Hauser RA
AD  - University of South Florida Parkinson's Disease and Movement Disorders Center,
      NPF Center of Excellence, Tampa, Florida, USA.
FAU - Klepiskaya, Olga S
AU  - Klepiskaya OS
AD  - University of Colorado School of Medicine, Denver, Colorado, USA.
FAU - Kreitzman, David L
AU  - Kreitzman DL
AD  - Parkinson's Disease and Movement Disorder Center of Long Island, Commack, New
      York, USA.
FAU - Lew, Mark F
AU  - Lew MF
AD  - University of Southern California (USC)/Keck School of Medicine, Los Angeles,
      California, USA.
FAU - Russell, David S
AU  - Russell DS
AD  - Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA.
FAU - Kadosh, Shaul
AU  - Kadosh S
AD  - StatExcellence Ltd, Nesher, Israel.
FAU - Litman, Pninit
AU  - Litman P
AD  - Pharma Two B Ltd, Rehovot, Israel.
FAU - Friedman, Hadas
AU  - Friedman H
AD  - Pharma Two B Ltd, Rehovot, Israel.
FAU - Linvah, Nurit
AU  - Linvah N
AD  - Pharma Two B Ltd, Rehovot, Israel.
FAU - The P B Study Group, For
AU  - The P B Study Group F
AD  - Clintrex LLC, Rye, New York, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170403
PL  - United States
TA  - Mov Disord
JT  - Movement disorders : official journal of the Movement Disorder Society
JID - 8610688
RN  - 0 (Antiparkinson Agents)
RN  - 0 (Benzothiazoles)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Drug Combinations)
RN  - 0 (Indans)
RN  - 0 (Neuroprotective Agents)
RN  - 003N66TS6T (rasagiline)
RN  - 83619PEU5T (pramipexole)
RN  - F7IY6HZG9D (Triethylenemelamine)
SB  - IM
MH  - Aged
MH  - Antiparkinson Agents/*therapeutic use
MH  - Benzothiazoles/*therapeutic use
MH  - Delayed-Action Preparations
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Indans/*therapeutic use
MH  - Israel
MH  - Male
MH  - Middle Aged
MH  - Neuroprotective Agents/*therapeutic use
MH  - Parkinson Disease/*drug therapy
MH  - Severity of Illness Index
MH  - Triethylenemelamine
MH  - United States
OTO - NOTNLM
OT  - *P2B001
OT  - *Parkinson's disease
OT  - *Pramipexole
OT  - *Rasagiline
EDAT- 2017/04/04 06:00
MHDA- 2018/02/07 06:00
CRDT- 2017/04/04 06:00
PHST- 2016/10/18 00:00 [received]
PHST- 2016/12/19 00:00 [revised]
PHST- 2016/12/28 00:00 [accepted]
PHST- 2017/04/04 06:00 [pubmed]
PHST- 2018/02/07 06:00 [medline]
PHST- 2017/04/04 06:00 [entrez]
AID - 10.1002/mds.26941 [doi]
PST - ppublish
SO  - Mov Disord. 2017 May;32(5):783-789. doi: 10.1002/mds.26941. Epub 2017 Apr 3.