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NCT03329508 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Parkinson Disease and Early Parkinson's Disease, sponsored by Pharma Two B.

Completed
Registry status
Phase 3
Development phase
544
Enrollment target
20
Study locations

NCT03329508 is a Phase 3 study of Parkinson Disease and Early Parkinson's Disease that has completed, run by Pharma Two B. The registered enrollment target is 544 participants, below the 5,325-participant average among 297 other Parkinson Disease trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT03329508, a Phase 3 study of Parkinson Disease and Early Parkinson's Disease, has completed, sponsored by Pharma Two B.

COMPLETED
Registry status
Phase 3
Development phase
544 participants
Enrollment target
20
Study locations

Study 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 Studied

Parkinson Disease Early Parkinson's Disease

Interventions

  • DRUG P2B001 0.6/0.75 mg
  • DRUG Rasagiline 0.75 mg
  • DRUG Pramipexole 0.6 mg
  • DRUG Marketed Pramipexole ER

Study Locations (20)

Florida

  • P2B001/003 site Boca Raton - Boca Raton
  • P2B001/003 Site Boca Raton - Boca Raton
  • P2B001/003 study site Jacksonville - Jacksonville
  • P2B001/003 site Miami - Miami
  • P2B001/003 Site Port Charlotte - Port Charlotte
  • P2B001/003 Site Sarasota - Sarasota
  • P2B001/003 Site Tampa - Tampa

Arizona

  • P2B001/003 Site Scottsdale - Scottsdale
  • P2B001/003 study site Scottsdale - Scottsdale

Illinois

  • P2B001/003 site Chicago - Chicago
  • P2B001/003 Site Winfield - Winfield

Arkansas

  • P2B001/003 Study site little Rock - Little Rock

California

  • P2B001 site Los Angeles - Los Angeles

Colorado

  • P2B001 Study site Englewood, - Englewood

Connecticut

  • P2B001 Study Vernon - Vernon

Georgia

  • P2B001/003 Site Augusta - Augusta

Trial Details

FieldValue
Enrollment Target 544 participants
Start Date 2018-01-19
Est. Completion 2021-10-31
Phase Phase 3

Sponsor

Pharma Two B

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03329508

The ClinicalTrials.gov registry entry for NCT03329508 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,325-participant average among 297 other Parkinson Disease trials with a reported enrollment target (90% lower). The listed sponsor is Pharma Two B, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 4 interventions - of which P2B001 0.6/0.75 mg is the first listed.

NCT03329508 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Arizona, Illinois.

Frequently Asked Questions

What is clinical trial NCT03329508 about?

NCT03329508 is a clinical study titled "A Phase 3 Study With P2B001 in Subjects With Early Parkinson's". 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 t...

What is the current status of trial NCT03329508?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2018-01-19. Estimated completion is 2021-10-31.

What conditions does trial NCT03329508 study?

This clinical trial studies the following conditions: Parkinson Disease, Early Parkinson's Disease.

What interventions are being tested in trial NCT03329508?

The interventions under investigation include: P2B001 0.6/0.75 mg (DRUG), Rasagiline 0.75 mg (DRUG), Pramipexole 0.6 mg (DRUG), Marketed Pramipexole ER (DRUG).

Who is sponsoring clinical trial NCT03329508?

This trial is sponsored by Pharma Two B, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03329508 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.