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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 : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : May 21, 2021
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 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. 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)
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 : August 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

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

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.

Information from the National Library of Medicine

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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

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

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Sponsors and Collaborators
Pharma Two B Ltd.
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Study Director: Pninit Litman Pharma2b LTD
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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: May 21, 2021
Last Verified: September 2020

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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
Neurodegenerative Diseases
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