Clinical trial NCT01968460: Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Rasagiline, Pramipexole
Lead sponsor: Pharma Two B Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-24
Enrollment: 149
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total UPDRS I, II, III Scores
timeFrame: Week 12
Secondary outcomes:
measure: UPDRS ADL (Part II)
timeFrame: Week 12
measure: CGI-S
timeFrame: 12 weeks
measure: UPDRS Motor (Part III)
timeFrame: 12 weeks
measure: PDQ39
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: P2B001 Site Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: P2B001 Site Los Angeles
state: California
city: Aurora
country: United States
facility: P2B001 Site Aurora
state: Colorado
city: Manchester
country: United States
facility: P2B001 Manchester
state: Connecticut
city: New Haven
country: United States
facility: P2B001 Site New Haven
state: Connecticut
city: Boca Raton
country: United States
facility: P2B001 Site Boca Raton
state: Florida
city: Port Charlotte
country: United States
facility: P2B001 Site Port Charlotte
state: Florida
city: Tampa
country: United States
facility: P2B001 Site Tampa
state: Florida
city: Augusta
country: United States
facility: P2B001 Site Augusta
state: Georgia
city: Chicago
country: United States
facility: P2B001 site Chicago
state: Illinois
city: Kansas City
country: United States
facility: P2B001 Site Kansas City
state: Kansas
city: Boston
country: United States
facility: P2B001 Site Boston
state: Massachusetts
city: West Bloomfield
country: United States
facility: P2B001 Site west Bloomfield
state: Michigan
city: Golden Valley
country: United States
facility: P2B001 Site Golden Valley
state: Minnesota
city: Camden
country: United States
facility: P2B001 Site Camden
state: New Jersey
city: New Brunswick
country: United States
facility: P2B001 Site New Brunswick
state: New Jersey
city: Commack
country: United States
facility: P2B001 site Commack
state: New York
city: New York
country: United States
facility: P2B001 Site New York
state: New York
city: Durham
country: United States
facility: P2B001 Site Durham
state: North Carolina
city: Cincinnati
country: United States
facility: P2B001 Site Cincinnati
state: Ohio
city: Toledo
country: United States
facility: P2B001 Site Toledo
state: Ohio
city: Tulsa
country: United States
facility: P2B001 Site Tulsa
state: Oklahoma
city: Houston
country: United States
facility: P2B001 Site Houston
state: Texas
city: Roanoke
country: United States
facility: P2B001 Site Roanoke
state: Virginia
city: Haifa
country: Israel
facility: P2B001 Site Rambam Israel
city: Pethch Tikva
country: Israel
facility: P2B001 Site Belinson
city: Ramat Gan
country: Israel
facility: P2B001 Site Sheba Medical Center
city: Rishon LeZion
country: Israel
facility: P2B001 Site Asaf Harofe
city: Tel Aviv
country: Israel
facility: P2B001 Site Sourasky Medical Center
Study officials:
affiliation: Pharma Two B Ltd.
name: pninit litman, Ph.D
role: STUDY_DIRECTOR
References: