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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968460
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pharma Two B Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg), Drug: Placebo Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg), Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: P2B001 Treatment A
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),
Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
Experimental: P2B001 Treatment B
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),
Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
Placebo Comparator: Placebo
Placebo once daily for 12 weeks.
 Drug: Placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Total UPDRS I, II, III scores [ Time Frame: Week 12 ]
    Change from baseline to final visit (week 12) in total UPDRS score (defined as sum of parts I, II and III, scores (0-176).


Secondary Outcome Measures :
  1. UPDRS ADL (part II) [ Time Frame: Week 12 ]
    Change from baseline in individual UPDRS ADL (part II)

  2. CGI-S [ Time Frame: 12 weeks ]
    Change from baseline in individual Clinical Global Impression - Severity

  3. UPDRS Motor (part III) [ Time Frame: 12 weeks ]
    Change from baseline in individual UPDRS motor (part III)

  4. PDQ39 [ Time Frame: 12 weeks ]
    Change from baseline in individual Parkinson's Disease Questionnaire - 39


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968460


Locations
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Sponsors and Collaborators
Pharma Two B Ltd.
Investigators
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Study Director: pninit litman, Ph.D Pharma Two B Ltd.
More Information
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Responsible Party: Pharma Two B Ltd.
ClinicalTrials.gov Identifier: NCT01968460    
Other Study ID Numbers: P2B001/001
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: February 2015
Keywords provided by Pharma Two B Ltd.:
Parkinson's Disease, Rasagiline, Pramipexole
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Pramipexole
Rasagiline
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents