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

NCT03329508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2023-03-21

Study results available
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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.

Conditions

  • Parkinson Disease
  • Early Parkinson's Disease

Interventions

DRUG

P2B001 0.6/0.75 mg

Fixed low dose extended release combination capsule of pramipexole and rasagiline

DRUG

Rasagiline 0.75 mg

Rasagiline 0.75 mg oral extended release capsule, component

DRUG

Pramipexole 0.6 mg

Pramipexole 0.6 mg oral extended release capsule, component

DRUG

Marketed Pramipexole ER

Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet

Sponsors & Collaborators

  • Pharma Two B Ltd.

    lead INDUSTRY

Principal Investigators

  • Pninit Litman · Pharma2b LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-19
Primary Completion
2021-08-23
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329508 on ClinicalTrials.gov