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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
Sponsor:
Information provided by (Responsible Party):
Pharma Two B Ltd.

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE January 29, 2018
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
change in total 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • 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 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Official Title  ICMJE 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.
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Parkinson Disease
  • Early Parkinson's Disease
Intervention  ICMJE
  • Drug: P2B001
    Fixed dose once daily combination capsule of pramipexole and rasagiline
    Other Name: Fixed dose combination of Pramipexole and rasagiline
  • Drug: Rasagiline
    Rasagiline oral capsule
    Other Name: rasagiline capsule
  • Drug: Pramipexole
    Pramipexole low dose oral capsule
    Other Name: Pramipexole capsule
  • Drug: Pramipexole ER
    Pramipexole ER titrated to optimal dose
    Other Name: Pramipexole Extended Release Oral Tablet
Study Arms  ICMJE
  • Experimental: P2B001
    Fixed dose combination once daily capsule of pramipexole and rasagiline
    Intervention: Drug: P2B001
  • Experimental: rasagiline capsule
    rasagiline Once daily capsule
    Intervention: Drug: Rasagiline
  • Experimental: Pramipexole capsule
    Pramipexole once daily capsule
    Intervention: Drug: Pramipexole
  • Active Comparator: Pramipexole Extended Release
    pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg
    Intervention: Drug: Pramipexole ER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
525
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03329508
Other Study ID Numbers  ICMJE P2B001/003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharma Two B Ltd.
Study Sponsor  ICMJE Pharma Two B Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pninit Litman Pharma2b LTD
PRS Account Pharma Two B Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP