A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Condition: Parkinson Disease; Early Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: P2B001 0.6/0.75 mg; Rasagiline 0.75 mg; Pramipexole 0.6 mg; Marketed Pramipexole ER
Intervention description: Fixed low dose extended release combination capsule of pramipexole and rasagiline; Rasagiline 0.75 mg oral extended release capsule, component; Pramipexole 0.6 mg oral extended release capsule, component; Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet
Intervention MeSH terms: Pramipexole; Rasagiline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 arms
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: double blind study
Enrollment: 544.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Parkinson disease; early Parkinson's Disease; Parkinson's diagnosis; Parkinson's tretment; Parkinson's medications

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.
    

Eligibility 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.