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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 : Recruiting

First Posted : November 6, 2017

Last Update Posted : January 11, 2019

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Pharma Two B Ltd.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson 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.

Study Design


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 :	September 30, 2019
Estimated Study Completion Date :	December 30, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Pramipexole dihydrochloride Pramipexole Rasagiline Rasagiline mesylate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome 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 Outcome 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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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.
Subject with disease duration less than 3 years since diagnosis.
Subject has a H&Y stage score of < 3.
Subject has a MMSE score ≥ 26.

Exclusion Criteria:

Subject has an atypical parkinsonian syndrome or secondary parkinsonism
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.
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.
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.
Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

Contacts and Locations

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

Contacts


Contact: Avigail Glass	89472672	Avigail@pharma2b.com
Contact: Pninit Litman		pninit@pharma2b.com

Show 65 Study Locations

Sponsors and Collaborators

Pharma Two B Ltd.

Investigators


Study Director:	Pninit Litman	Pharma2b LTD

More Information


Responsible Party:	Pharma Two B Ltd.
ClinicalTrials.gov Identifier:	NCT03329508 History of Changes
Other Study ID Numbers:	P2B001/003
First Posted:	November 6, 2017 Key Record Dates
Last Update Posted:	January 11, 2019
Last Verified:	March 2018


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

Additional relevant MeSH terms:


Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Pramipexole Rasagiline Antioxidants	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

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