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

NCT ID: NCT01968460

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

Brief 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

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Placebo

Placebo once daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo

Interventions

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

Intervention Type: DRUG

Placebo

placebo

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject is male or female ≥35 years of age to ≤75 years of age at the time of enrollment.
• Subject has idiopathic Parkinson's disease consistent with the UK Brain Bank Criteria; must have bradykinesia with sequence effect and rest tremor or prominent motor asymmetry.
• Subject with disease duration no longer than 3 years and 0 months.
• Subject has a Hoehn & Yahr (H&Y) stage score of < 3.
• Subject has a MMSE score ≥ 26

Exclusion Criteria

• Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
• Subject has a history of psychosis or hallucinations within the previous 12 months.
• Subject who is taking anticholinergic drugs.
• Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
• Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
• Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharma Two B Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

pninit litman, Ph.D

Role: STUDY_DIRECTOR

Pharma Two B Ltd.

Locations

P2B001 Site Birmingham

Birmingham, Alabama, United States

P2B001 Site Los Angeles

Los Angeles, California, United States

P2B001 Site Aurora

Aurora, Colorado, United States

P2B001 Manchester

Manchester, Connecticut, United States

P2B001 Site New Haven

New Haven, Connecticut, United States

P2B001 Site Boca Raton

Boca Raton, Florida, United States

P2B001 Site Port Charlotte

Port Charlotte, Florida, United States

P2B001 Site Tampa

Tampa, Florida, United States

P2B001 Site Augusta

Augusta, Georgia, United States

P2B001 site Chicago

Chicago, Illinois, United States

P2B001 Site Kansas City

Kansas City, Kansas, United States

P2B001 Site Boston

Boston, Massachusetts, United States

P2B001 Site west Bloomfield

West Bloomfield, Michigan, United States

P2B001 Site Golden Valley

Golden Valley, Minnesota, United States

P2B001 Site Camden

Camden, New Jersey, United States

P2B001 Site New Brunswick

New Brunswick, New Jersey, United States

P2B001 site Commack

Commack, New York, United States

P2B001 Site New York

New York, New York, United States

P2B001 Site Durham

Durham, North Carolina, United States

P2B001 Site Cincinnati

Cincinnati, Ohio, United States

P2B001 Site Toledo

Toledo, Ohio, United States

P2B001 Site Tulsa

Tulsa, Oklahoma, United States

P2B001 Site Houston

Houston, Texas, United States

P2B001 Site Roanoke

Roanoke, Virginia, United States

P2B001 Site Rambam Israel

Haifa, , Israel

P2B001 Site Belinson

Pethch Tikva, , Israel

P2B001 Site Sheba Medical Center

Ramat Gan, , Israel

P2B001 Site Asaf Harofe

Rishon LeZiyyon, , Israel

P2B001 Site Sourasky Medical Center

Tel Aviv, , Israel

Countries

United States; Israel

Other Identifiers

P2B001/001

Identifier Type: -

Identifier Source: org_study_id