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

NCT01968460 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-04-07

Study results available
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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

Interventions

DRUG

P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),

Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily

DRUG

Placebo

placebo

DRUG

P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),

Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily

Sponsors & Collaborators

  • Pharma Two B Ltd.

    lead INDUSTRY

Principal Investigators

  • pninit litman, Ph.D · Pharma Two B Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States
  • Israel

Study Locations

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Entities

Drugs
Diseases

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 NCT01968460 on ClinicalTrials.gov