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NCT01968460 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Parkinson's Disease, sponsored by Pharma Two B.

Completed
Registry status
Phase 2
Development phase
149
Enrollment target
20
Study locations

NCT01968460 is a Phase 2 study of Parkinson's Disease that has completed, run by Pharma Two B. The registered enrollment target is 149 participants, below the 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01968460, a Phase 2 study of Parkinson's Disease, has completed, sponsored by Pharma Two B.

COMPLETED
Registry status
Phase 2
Development phase
149 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Parkinson's Disease

Interventions

  • DRUG Placebo
  • DRUG P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),
  • DRUG P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

Study Locations (20)

Florida

  • P2B001 Site Boca Raton - Boca Raton
  • P2B001 Site Port Charlotte - Port Charlotte
  • P2B001 Site Tampa - Tampa

Connecticut

  • P2B001 Manchester - Manchester
  • P2B001 Site New Haven - New Haven

New Jersey

  • P2B001 Site Camden - Camden
  • P2B001 Site New Brunswick - New Brunswick

New York

  • P2B001 site Commack - Commack
  • P2B001 Site New York - New York

Alabama

  • P2B001 Site Birmingham - Birmingham

California

  • P2B001 Site Los Angeles - Los Angeles

Colorado

  • P2B001 Site Aurora - Aurora

Georgia

  • P2B001 Site Augusta - Augusta

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2013-12
Est. Completion 2015-06
Phase Phase 2

Sponsor

Pharma Two B

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01968460

The ClinicalTrials.gov registry entry for NCT01968460 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 641-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (77% lower). The listed sponsor is Pharma Two B, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01968460 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, Connecticut, New Jersey.

Frequently Asked Questions

What is clinical trial NCT01968460 about?

NCT01968460 is a clinical study titled "Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease". 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 ar...

What is the current status of trial NCT01968460?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2013-12. Estimated completion is 2015-06.

What conditions does trial NCT01968460 study?

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

What interventions are being tested in trial NCT01968460?

The interventions under investigation include: Placebo (DRUG), P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), (DRUG), P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), (DRUG).

Who is sponsoring clinical trial NCT01968460?

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

Where is trial NCT01968460 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.