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

NCT01968460 | Completed Phase 2 Results DMC

• 1 other identifier: P2B001/001
• Study Type: interventional
• Target: 149
• Locations: 2 countries
• Sites: 29

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

Keywords

Parkinson's Disease, Rasagiline, Pramipexole

Outcome Measures

Primary Outcomes (1)

• Total UPDRS I, II, III Scores

  Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176). UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 176. High score mean worse outcome.

  Week 12

Secondary Outcomes (4)

• UPDRS ADL (Part II)

  Week 12

• CGI-S

  12 weeks

• UPDRS Motor (Part III)

  12 weeks

• PDQ39

  12 weeks

Study Arms (3)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

Placebo once daily for 12 weeks.

Drug: Placebo

Interventions

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

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

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

Placebo DRUG

placebo

Placebo

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

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

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

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharma Two B Ltd.: lead

Study Sites (29)

P2B001 Site Birmingham

Birmingham, Alabama, United States

Location

P2B001 Site Los Angeles

Los Angeles, California, United States

Location

P2B001 Site Aurora

Aurora, Colorado, United States

Location

P2B001 Manchester

Manchester, Connecticut, United States

Location

P2B001 Site New Haven

New Haven, Connecticut, United States

Location

P2B001 Site Boca Raton

Boca Raton, Florida, United States

Location

P2B001 Site Port Charlotte

Port Charlotte, Florida, United States

Location

P2B001 Site Tampa

Tampa, Florida, United States

Location

P2B001 Site Augusta

Augusta, Georgia, United States

Location

P2B001 site Chicago

Chicago, Illinois, 60612, United States

Location

P2B001 Site Kansas City

Kansas City, Kansas, United States

Location

P2B001 Site Boston

Boston, Massachusetts, United States

Location

P2B001 Site west Bloomfield

West Bloomfield, Michigan, United States

Location

P2B001 Site Golden Valley

Golden Valley, Minnesota, United States

Location

P2B001 Site Camden

Camden, New Jersey, United States

Location

P2B001 Site New Brunswick

New Brunswick, New Jersey, United States

Location

P2B001 site Commack

Commack, New York, United States

Location

P2B001 Site New York

New York, New York, United States

Location

P2B001 Site Durham

Durham, North Carolina, United States

Location

P2B001 Site Cincinnati

Cincinnati, Ohio, United States

Location

P2B001 Site Toledo

Toledo, Ohio, United States

Location

P2B001 Site Tulsa

Tulsa, Oklahoma, United States

Location

P2B001 Site Houston

Houston, Texas, United States

Location

P2B001 Site Roanoke

Roanoke, Virginia, United States

Location

P2B001 Site Rambam Israel

Haifa, Israel

Location

P2B001 Site Belinson

Pethch Tikva, Israel

Location

P2B001 Site Sheba Medical Center

Ramat Gan, Israel

Location

P2B001 Site Asaf Harofe

Rishon LeZiyyon, Israel

Location

P2B001 Site Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole; rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pninit Litman study director
• Organization: Pharma 2B LTD

pninit@pharma2b.com

+972 8 9472672

Study Officials

• pninit litman, Ph.D

  Pharma Two B Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 24, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2015-02

Locations

IL (5); US (24)