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

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: NCT03329508
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : March 21, 2023
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Pharma Two B Ltd.

Brief Summary:

P2B001 is an investigational drug that comprised of low doses of two drugs, pramipexole and rasagiline, which are both approved drugs and routinely used in standard therapy for Parkinson's disease. The two drugs work in two different mechanisms that help each other, so there is a reason to believe that their combined activity will be better than each individual drug, and that lower doses can be used without losing the therapeutic effect. Thus, the development of P2B001 is intended to provide a combination of low doses of these two drugs, in an improved formulation, that is hoped to be more effective in controlling Parkinson's disease symptoms and with less side effects than each of the drugs taken alone or the current available commercial drugs taken together. In a previously completed clinical trial a significant improvement in Parkinson's disease symptoms was seen in patients treated with P2B001 compared to patients that were treated with placebo.

In this phase 3 study , the safety and efficacy of P2B001 will be assessed by comparing P2B001 to its individual components pramipexole and rasagiline. This will be done by monitoring the motor and non-motor symptoms, evaluating responses participants provide on questionnaires relating to Parkinson's disease and quality of life that will be completed on every visit. In addition, this study will also compare P2B001 to a marketed drug of pramipexole ER. Approximately 525 patients will participate in this research study and the participation in this study will last between 14 to 18 weeks.


Condition or disease Intervention/treatment Phase
Parkinson Disease Early Parkinson's Disease Drug: P2B001 0.6/0.75 mg Drug: Rasagiline 0.75 mg Drug: Pramipexole 0.6 mg Drug: Marketed 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. Subjects will be requested to take one capsule and 1-3 tablets of study drug by mouth with a glass of water every day for 13 weeks. The study requires seven visits to the clinic one every 2-4 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 544 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 19, 2018
Actual Primary Completion Date : August 23, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: P2B001 0.6/0.75 mg
Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet
Drug: P2B001 0.6/0.75 mg
Fixed low dose extended release combination capsule of pramipexole and rasagiline
Other Name: P2B001 capsule

Experimental: rasagiline 0.75mg
Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
Drug: Rasagiline 0.75 mg
Rasagiline 0.75 mg oral extended release capsule, component
Other Name: RAS 0.75

Experimental: Pramipexole 0.6mg
Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet
Drug: Pramipexole 0.6 mg
Pramipexole 0.6 mg oral extended release capsule, component
Other Name: PPX 0.6

Active Comparator: Pramipexole Extended Release
Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule
Drug: Marketed Pramipexole ER
Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet
Other Name: PramiER




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 ]

    Differences between 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).

    UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160.

    High score mean worse outcome.



Secondary Outcome Measures :
  1. Change in Epworth Sleepiness Scale (ESS) Score. [ Time Frame: baseline to week 12 ]

    Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score.

    Scale is 0-24 , when 24 is worse outcome


  2. Change From Baseline to Week 12 in Total UPDRS III Motor [ Time Frame: baseline to week 12 ]

    Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ).

    UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)


  3. Change From Baseline to Week 12 in Total UPDRS II ADL [ Time Frame: Baseline to week 12 ]
    Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)

  4. Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39 [ Time Frame: Baseline to week 12 ]

    The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose.

    ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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


Locations
Show Show 72 study locations
Sponsors and Collaborators
Pharma Two B Ltd.
Investigators
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Study Director: Pninit Litman Pharma2b LTD
  Study Documents (Full-Text)

Documents provided by Pharma Two B Ltd.:
Study Protocol  [PDF] November 18, 2020
Informed Consent Form  [PDF] August 5, 2019

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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
Results First Posted: March 21, 2023
Last Update Posted: March 21, 2023
Last Verified: June 2022

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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
early Parkinson's Disease
Parkinson's diagnosis
Parkinson's tretment
Parkinson's medications
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