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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT03329508 |
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Date of registration:
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30/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
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Scientific title:
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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. |
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Date of first enrolment:
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January 19, 2018 |
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Target sample size:
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544 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03329508 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Germany
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Spain
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United States
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Contacts
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Name:
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Pninit Litman |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pharma2b LTD |
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Key inclusion & exclusion criteria
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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.
Age minimum:
35 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Early Parkinson's Disease
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Parkinson Disease
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Intervention(s)
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Drug: Pramipexole 0.6 mg
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Drug: Rasagiline 0.75 mg
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Drug: P2B001 0.6/0.75 mg
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Drug: Marketed Pramipexole ER
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
[Time Frame: Baseline to week 12]
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Change From Baseline to Week 12 in Total UPDRS III Motor
[Time Frame: baseline to week 12]
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Change From Baseline to Week 12 in Total UPDRS II ADL
[Time Frame: Baseline to week 12]
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Change in Epworth Sleepiness Scale (ESS) Score.
[Time Frame: baseline to week 12]
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Secondary ID(s)
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P2B001/003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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