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

Phase 2

Completed

Conditions: Parkinson's Disease

Interventions: Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Drug: Placebo

Registration Number: NCT01968460

Lead Sponsor: Pharma Two B Ltd.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 149

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),	P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),	Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily.
P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),	P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),	Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
Placebo	Placebo	Placebo once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Total UPDRS I, II, III Scores	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
UPDRS ADL (Part II)	Week 12	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)
CGI-S	12 weeks	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.
UPDRS Motor (Part III)	12 weeks	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)
PDQ39	12 weeks	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.

Trial Locations

Locations (29): P2B001 Site Los Angeles
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Los Angeles, California, United States
P2B001 Manchester
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Manchester, Connecticut, United States
P2B001 Site Sourasky Medical Center
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Tel Aviv, Israel
P2B001 Site Golden Valley
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Golden Valley, Minnesota, United States
P2B001 Site Augusta
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Augusta, Georgia, United States
P2B001 Site Kansas City
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Kansas City, Kansas, United States
P2B001 Site Rambam Israel
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Haifa, Israel
P2B001 Site Asaf Harofe
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Rishon LeZion, Israel
P2B001 Site Toledo
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Toledo, Ohio, United States
P2B001 Site Sheba Medical Center
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Ramat Gan, Israel
P2B001 Site Roanoke
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Roanoke, Virginia, United States
P2B001 Site Belinson
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Pethch Tikva, Israel
P2B001 Site New Haven
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New Haven, Connecticut, United States
P2B001 Site Port Charlotte
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Port Charlotte, Florida, United States
P2B001 Site Boca Raton
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Boca Raton, Florida, United States
P2B001 Site west Bloomfield
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West Bloomfield, Michigan, United States
P2B001 Site Camden
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Camden, New Jersey, United States
P2B001 Site New Brunswick
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New Brunswick, New Jersey, United States
P2B001 Site New York
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New York, New York, United States
P2B001 site Commack
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Commack, New York, United States
P2B001 Site Tulsa
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Tulsa, Oklahoma, United States
P2B001 Site Birmingham
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Birmingham, Alabama, United States
P2B001 Site Aurora
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Aurora, Colorado, United States
P2B001 Site Tampa
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Tampa, Florida, United States
P2B001 site Chicago
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Chicago, Illinois, United States
P2B001 Site Boston
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Boston, Massachusetts, United States
P2B001 Site Durham
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Durham, North Carolina, United States
P2B001 Site Cincinnati
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Cincinnati, Ohio, United States
P2B001 Site Houston
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Houston, Texas, United States