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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 30, 2020

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.

Interventions

  • Drug: P2B001
    • Fixed dose once daily combination capsule of pramipexole and rasagiline
  • Drug: Rasagiline
    • Rasagiline oral capsule
  • Drug: Pramipexole
    • Pramipexole low dose oral capsule
  • Drug: Pramipexole ER
    • Pramipexole ER titrated to optimal dose

Arms, Groups and Cohorts

  • Experimental: P2B001
    • Fixed dose combination once daily capsule of pramipexole and rasagiline
  • Experimental: rasagiline capsule
    • rasagiline Once daily capsule
  • Experimental: Pramipexole capsule
    • Pramipexole once daily capsule
  • Active Comparator: Pramipexole Extended Release
    • pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pharma Two B Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pninit Litman, Study Director, Pharma2b LTD
  • Overall Contact(s)
    • Avigail Glass, 89472672, Avigail@pharma2b.com

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