Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:35 - 75
Updated:11/2/2017
Start Date:December 2013
End Date:June 2015

Use our guide to learn which trials are right for you!

A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and
rasagiline for the treatment of early Parkinson's disease.

Animal studies support the therapeutic advantage of combining low doses of rasagiline and
pramipexole and suggest further improvement when both are administered in a sustained
fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's
disease with a good safety profile. combining the drugs in low doses and controlled release
may provide better symptom management than the existing drugs alone or together.


Inclusion Criteria:

- Subject is male or female ≥35 years of age to ≤75 years of age at the time of
enrollment.

- Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria;
must have bradykinesia with sequence effect and rest tremor or prominent motor
asymmetry.

- Subject with disease duration no longer than 3 years and 0 months.

- Subject has a Hoehn & Yahr (H&Y) stage score of < 3.

- Subject has a MMSE score ≥ 26

Exclusion Criteria:

- Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to
drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or
degenerative disease).

- Subject has a history of psychosis or hallucinations within the previous 12 months.

- Subject who is taking anticholinergic drugs.

- Subject has previous exposure to levodopa or a dopamine agonist for longer than 4
weeks; if previous exposure was less than 4 weeks then it must not be within 2 months
prior to the baseline visit.

- Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if
previous exposure was less than 4 weeks then it must not be within 3 months prior to
the baseline visit.

- Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin,
Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine,
methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or
cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the
neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide.
Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine.
We found this trial at
25
sites
Birmingham, Alabama
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Augusta, Georgia
2057
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
Aurora, Colorado
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
?
mi
from 91732
Beer Yakov,
Click here to add this to my saved trials
Boca Raton, Florida
2312
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
Camden, New Jersey
2377
mi
from 91732
Camden, NJ
Click here to add this to my saved trials
Chicago, Illinois 60612
1726
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio
1882
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Commack, New York
2469
mi
from 91732
Commack, NY
Click here to add this to my saved trials
Durham, North Carolina
2201
mi
from 91732
Durham, NC
Click here to add this to my saved trials
Golden valley, Minnesota
1506
mi
from 91732
Golden valley, MN
Click here to add this to my saved trials
Houston, Texas
1358
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Kansas City, Kansas
1339
mi
from 91732
Kansas City, KS
Click here to add this to my saved trials
Los Angeles, California
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Manchester, Connecticut
2505
mi
from 91732
Manchester, CT
Click here to add this to my saved trials
New Brunswick, New Jersey
2410
mi
from 91732
New Brunswick, NJ
Click here to add this to my saved trials
New Haven, Connecticut
2486
mi
from 91732
New Haven, CT
Click here to add this to my saved trials
New York, New York
2351
mi
from 91732
New York, NY
Click here to add this to my saved trials
Port Charlotte, Florida
2181
mi
from 91732
Port Charlotte, FL
Click here to add this to my saved trials
Roanoke, Virginia
2133
mi
from 91732
Roanoke, VA
Click here to add this to my saved trials
Tampa, Florida
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
Toledo, Ohio
1936
mi
from 91732
Toledo, OH
Click here to add this to my saved trials
Tulsa, Oklahoma
1250
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
West Bloomfield Township, Michigan
1951
mi
from 91732
West Bloomfield Township, MI
Click here to add this to my saved trials