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A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

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ClinicalTrials.gov Identifier: NCT03329508
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Pharma Two B Ltd.

Study Description
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Brief Summary:
A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: P2B001 Drug: Rasagiline Drug: Pramipexole Drug: Pramipexole ER Phase 3

Detailed Description:
A total of 525 eligible subjects with early untreated Parkinson's disease (PD), will be randomized to 4 treatment groups. Each subject will participate in the study for approximately 18 weeks including a 30 day screening period, 12 week treatment period, and 2 weeks follow-up period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4 arms
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blind study
Primary Purpose: Treatment
Official Title: A Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : February 28, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: P2B001
Fixed dose combination once daily capsule of pramipexole and rasagiline
 Drug: P2B001
Fixed dose once daily combination capsule of pramipexole and rasagiline
Other Name: Fixed dose combination of Pramipexole and rasagiline
Experimental: rasagiline capsule
rasagiline Once daily capsule
 Drug: Rasagiline
Rasagiline oral capsule
Other Name: rasagiline capsule
Experimental: Pramipexole capsule
Pramipexole once daily capsule
 Drug: Pramipexole
Pramipexole low dose oral capsule
Other Name: Pramipexole capsule
Active Comparator: Pramipexole Extended Release
pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
 Drug: Pramipexole ER
Pramipexole ER titrated to optimal dose
Other Name: Pramipexole Extended Release Oral Tablet


Outcome Measures
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Primary Outcome Measures :
  1. change in total Unified Parkinson's Disease Rating Scale (UPDRS) score (defined as sum of parts II and III, scores (0-160). [ Time Frame: baseline to week 12 ]
    Superiority of P2B 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160).


Secondary Outcome Measures :
  1. Change in Epworth Sleepiness Scale (ESS) score. [ Time Frame: baseline to week 12 ]
    Superiority of P2B 0.6/0.75 mg as compared to pramipexole ER in the change of Epworth Sleepiness Scale (ESS) score.

  2. change of Total Parkinson's Disease Questionnaire 39 (PDQ39) score. [ Time Frame: baseline to week 12 ]
    The efficacy of P2B 0.6/0.75 mg as compared to its individual components in the change of Total PDQ39 score.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has Parkinson's disease consistent with the UK Brain Bank Criteria and must have bradykinesia with sequence effect. If rest tremor does not exist must have prominent asymmetry of motor function.
  2. Subject with disease duration less than 3 years since diagnosis.
  3. Subject has a H&Y stage score of < 3.
  4. Subject has a MMSE score ≥ 26.

Exclusion Criteria:

  1. Subject has an atypical parkinsonian syndrome or secondary parkinsonism
  2. 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.
  3. 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.
  4. Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit.
  5. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.
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): NCT03329508


Contacts
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Contact: Avigail Glass 89472672 Avigail@pharma2b.com
Contact: Pninit Litman pninit@pharma2b.com

Locations
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Sponsors and Collaborators
Pharma Two B Ltd.
Investigators
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Study Director: Pninit Litman Pharma2b LTD
More Information
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Responsible Party: Pharma Two B Ltd.
ClinicalTrials.gov Identifier: NCT03329508    
Other Study ID Numbers: P2B001/003
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharma Two B Ltd.:
Parkinson disease
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
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