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COMPLETED Phase 2

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

NCT01968460 · View on ClinicalTrials.gov ↗

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

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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharma Two B, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01968460 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Connecticut, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01968460?

This trial is sponsored by Pharma Two B, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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