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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968460
• Other study ID #: P2B001/001
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Pharma Two B Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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
• Placebo
placebo
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pharma Two B Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12
Secondary	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)	Week 12
Secondary	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.	12 weeks
Secondary	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)	12 weeks
Secondary	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.	12 weeks