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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
149
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
placebo
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
P2B001 Site Birmingham
Birmingham, Alabama, United States
P2B001 Site Los Angeles
Los Angeles, California, United States
P2B001 Site Aurora
Aurora, Colorado, United States
P2B001 Manchester
Manchester, Connecticut, United States
P2B001 Site New Haven
New Haven, Connecticut, United States
P2B001 Site Boca Raton
Boca Raton, Florida, United States
P2B001 Site Port Charlotte
Port Charlotte, Florida, United States
P2B001 Site Tampa
Tampa, Florida, United States
P2B001 Site Augusta
Augusta, Georgia, United States
P2B001 site Chicago
Chicago, Illinois, United States
...and 19 more locations
Total UPDRS I, II, III Scores
Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.
Time frame: Week 12
UPDRS ADL (Part II)
Change from baseline in individual UPDRS ADL (part II). Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)
Time frame: Week 12
CGI-S
Change from baseline in individual Clinical Global Impression - Severity. Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness (Parkinson's Disease) at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis as one of the following:. 1 is normal and 7 is the most extremely ill patients. A subject defined as a treatment responder when the improvement from baseline to the Week12 / Last Observed Value (LOV) was of at least 1 point or more.
Time frame: 12 weeks
UPDRS Motor (Part III)
Change from baseline in individual UPDRS motor (part III). UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)
Time frame: 12 weeks
PDQ39
Change from baseline in individual Parkinson's Disease Questionnaire - 39. Score 0-100 where 0 is indicative of no problem at all and 100 is the maximum level of problem.
Time frame: 12 weeks
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