A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

Parkinson Disease Clinical Trial

Official title:

A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329508
• Other study ID #: P2B001/003
• Status: Completed
• Phase: Phase 3
• Start date: January 19, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2022
• Source: Pharma Two B Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease. The two drugs work in two different mechanisms that help each other, so there is a reason to believe that their combined activity will be better than each individual drug, and that lower doses can be used without losing the therapeutic effect. Thus, the development of P2B001 is intended to provide a combination of low doses of these two drugs, in an improved formulation, that is hoped to be more effective in controlling Parkinson's disease symptoms and with less side effects than each of the drugs taken alone or the current available commercial drugs taken together. In a previously completed clinical trial a significant improvement in Parkinson's disease symptoms was seen in patients treated with P2B001 compared to patients that were treated with placebo.

In this phase 3 study , the safety and efficacy of P2B001 will be assessed by comparing P2B001 to its individual components pramipexole and rasagiline. This will be done by monitoring the motor and non-motor symptoms, evaluating responses participants provide on questionnaires relating to Parkinson's disease and quality of life that will be completed on every visit. In addition, this study will also compare P2B001 to a marketed drug of pramipexole ER. Approximately 525 patients will participate in this research study and the participation in this study will last between 14 to 18 weeks.

Description:

A total of 525 eligible subjects with early untreated Parkinson's disease (PD), will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30 day screening period, 12 week treatment period, and 2 weeks follow-up period. Subjects will be requested to take one capsule and 1-3 tablets of study drug by mouth with a glass of water every day for 13 weeks. The study requires seven visits to the clinic one every 2-4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: October 31, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject has Parkinson's disease consistent with the UK Brain Bank Criteria and must have bradykinesia with sequence effect. If rest tremor does not exist must have prominent asymmetry of motor function.

2. Subject with disease duration less than 3 years since diagnosis.

3. Subject has a H&Y stage score of < 3.

4. Subject has a MMSE score = 26.

Exclusion Criteria:

1. Subject has an atypical parkinsonian syndrome or secondary parkinsonism

2. 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.

3. 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.

4. Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit.

5. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

Related Conditions & MeSH terms

• Early Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• P2B001 0.6/0.75 mg
Fixed low dose extended release combination capsule of pramipexole and rasagiline
• Rasagiline 0.75 mg
Rasagiline 0.75 mg oral extended release capsule, component
• Pramipexole 0.6 mg
Pramipexole 0.6 mg oral extended release capsule, component
• Marketed Pramipexole ER
Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet

Locations

Country	Name	City	State
Canada	P2B001/003 study site Toronto	Toronto	Ontario
Germany	P2B001/003 Study site Berlin	Berlin
Germany	P2B001/003 Study site Berlin	Berlin
Germany	P2B001/003 Study site Bochum	Bochum	Nordrhein-westfalen
Germany	P2B001/003 Study site Dresden	Dresden	SaACHSEN
Germany	P2B001/003 Study site Freiburg	Freiburg	Baden-Württemberg
Germany	P2B001/003 Study site Gera	Gera	Thuringen
Germany	P2B001/003 study site Gera Germany	Gera	Thuringen
Germany	P2B001/003 study site Haag	Haag	Bayern
Germany	P2B001/003 Study site Haag	Haag	Bayern
Germany	P2B001/003 Study site Hanau	Hanau	Hessen
Germany	P2B001/003 study site Leipzig	Leipzig	Sachsen
Germany	P2B001/003 Study site München	München	Bayern
Germany	P2B001/003 site Munich	Munich
Germany	P2B001/003 Study site Münster	Münster	Nordrhein-westfalen
Germany	P2B001/003 study site Ulm	Ulm	Baden-wuerttemberg
Spain	P2B001/003 Study site Barcelona	Barcelona
Spain	P2B001/003 Study site Vall d'Hebrón	Barcelona
Spain	P2B001/003 Study site La Paz	Madrid	S
Spain	P2B001/003 study site Madrid	Madrid
Spain	P2B001/003 Study site Madrid	Madrid
Spain	P2B001/003 Study site Navarra Madrid	Madrid
Spain	P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)	Madrid
Spain	P2B001/003 Study site Puerta de Hierro - Majadahonda	Majadahonda
Spain	P2B001/003 study site Mostoles	Mostoles	Madridid
Spain	P2B001/003 Study site Pamplona	Pamplona	Navarra
Spain	P2B001/003 Study site Sant Cugat del Vallés	Sant Cugat del Vallés	Barcelona
United States	P2B001/003 Study site Albuquerque	Albuquerque	New Mexico
United States	P2B001/003 Study site Alexandria	Alexandria	Virginia
United States	P2B001/003 Site Asheville	Asheville	North Carolina
United States	P2B001/003 Site Augusta	Augusta	Georgia
United States	P2B001/003 site Boca Raton	Boca Raton	Florida
United States	P2B001/003 Site Boca Raton	Boca Raton	Florida
United States	P2B001/003 study site Boston	Boston	Massachusetts
United States	P2B001/003 Study site Brooklyn	Brooklyn	New York
United States	P2B001/003 Study site Camden	Camden	New Jersey
United States	P2B001/003 site Chicago	Chicago	Illinois
United States	P2B001 study site Cincinnati	Cincinnati	Ohio
United States	P2B001/003 Site Commack	Commack	New York
United States	P2B001/003 Site Dallas	Dallas	Texas
United States	P2B001/003 Site East Lansing	East Lansing	Michigan
United States	P2B001 Study site Edison	Edison	New Jersey
United States	P2B001 Study site Englewood,	Englewood	Colorado
United States	P2B001/003	Falls Church	Virginia
United States	P2B001/003 Site Golden Valley	Golden Valley	Minnesota
United States	P2B001/003 Greenville	Greenville	South Carolina
United States	P2B001/003 Study site Hershey	Hershey	Pennsylvania
United States	P2B001/003 study site Honolulu	Honolulu	Hawaii
United States	P2B001/003 study site Jacksonville	Jacksonville	Florida
United States	P2B001/003 site Kansas City	Kansas City	Kansas
United States	P2B001/003 Site Kirkland	Kirkland	Washington
United States	P2B001/003 study site New Hampshire	Lebanon	New Hampshire
United States	P2B001/003 Site Lexington	Lexington	Kentucky
United States	P2B001/003 Study site little Rock	Little Rock	Arkansas
United States	P2B001 site Los Angeles	Los Angeles	California
United States	p2B001/003 Study site Memphis	Memphis	Tennessee
United States	P2B0011/003 Study Veracity Neuroscience	Memphis	Tennessee
United States	P2B001/003 site Miami	Miami	Florida
United States	P2B001/003 Study site Nashville	Nashville	Tennessee
United States	P2B001/003 New York	New York	New York
United States	P2B001/003 Site Port Charlotte	Port Charlotte	Florida
United States	P2B001/003 site St. Louis	Saint Louis	Missouri
United States	P2B001/003 Site Sarasota	Sarasota	Florida
United States	P2B001/003 Site Scottsdale	Scottsdale	Arizona
United States	P2B001/003 study site Scottsdale	Scottsdale	Arizona
United States	P2B001 Study site Syracuse	Syracuse	New York
United States	P2B001/003 Site Tampa	Tampa	Florida
United States	P2B001/003 Site Toledo	Toledo	Ohio
United States	P2B001 Study Vernon	Vernon	Connecticut
United States	P2B001/003 study site west Bloomfield	West Bloomfield	Michigan
United States	P2B001/003 Study site Williamsville	Williamsville	New York
United States	P2B001/003 Site Winfield	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pharma Two B Ltd.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).	Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160).; UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160.; High score mean worse outcome.	baseline to week 12
Secondary	Change in Epworth Sleepiness Scale (ESS) Score.	Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score.; Scale is 0-24 , when 24 is worse outcome	baseline to week 12
Secondary	Change From Baseline to Week 12 in Total UPDRS III Motor	Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ).; UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)	baseline to week 12
Secondary	Change From Baseline to Week 12 in Total UPDRS II ADL	Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)	Baseline to week 12
Secondary	Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39	The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose.; ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome	Baseline to week 12