AzTrials
AzTrials

Parkinson DiseasePhase 3NCT03329508

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

A Phase 3 study testing P2B001 0.6/0.75 mg, Rasagiline 0.75 mg and Pramipexole 0.6 mg in people with Parkinson Disease and Early Parkinson's Disease, run by Pharma Two B Ltd. at 72 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Parkinson Disease, Early Parkinson's Disease
What is being tested?
P2B001 0.6/0.75 mg, Rasagiline 0.75 mg and Pramipexole 0.6 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 participants
Where
72 sitesin 4 countries
Study dates
19 Jan 2018to 31 Oct 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 4 countries.

72 sites in 4 countries

United States45 sites

  • P2B001/003 Study site Albuquerque

    Albuquerque, New Mexico, 87108

  • P2B001/003 Study site Alexandria

    Alexandria, Virginia, 22311

  • P2B001/003 Site Asheville

    Asheville, North Carolina, 28806

  • P2B001/003 Site Augusta

    Augusta, Georgia, 30912

  • P2B001/003 site Boca Raton

    Boca Raton, Florida, 33431

  • P2B001/003 Site Boca Raton

    Boca Raton, Florida, 33486

  • P2B001/003 study site Boston

    Boston, Massachusetts, 02118

  • P2B001/003 Study site Brooklyn

    Brooklyn, New York, 11203

  • P2B001/003 Study site Camden

    Camden, New Jersey, 08103

  • P2B001/003 site Chicago

    Chicago, Illinois, 60612

  • P2B001 study site Cincinnati

    Cincinnati, Ohio, 45219

  • P2B001/003 Site Commack

    Commack, New York, 11725

  • P2B001/003 Site Dallas

    Dallas, Texas, 75390

  • P2B001/003 Site East Lansing

    East Lansing, Michigan, 48824

  • P2B001 Study site Edison

    Edison, New Jersey, 08820

  • P2B001 Study site Englewood,

    Englewood, Colorado, 80113

  • P2B001/003

    Falls Church, Virginia, 22042

  • P2B001/003 Site Golden Valley

    Golden Valley, Minnesota, 55427

  • P2B001/003 Greenville

    Greenville, South Carolina, 29615

  • P2B001/003 Study site Hershey

    Hershey, Pennsylvania, 17033

  • P2B001/003 study site Honolulu

    Honolulu, Hawaii, 96819

  • P2B001/003 study site Jacksonville

    Jacksonville, Florida, 32209

  • P2B001/003 site Kansas City

    Kansas City, Kansas, 66160

  • P2B001/003 Site Kirkland

    Kirkland, Washington, 98034

  • P2B001/003 study site New Hampshire

    Lebanon, New Hampshire, 03756

  • P2B001/003 Site Lexington

    Lexington, Kentucky, 40536

  • P2B001/003 Study site little Rock

    Little Rock, Arkansas, 72205

  • P2B001 site Los Angeles

    Los Angeles, California, 90033

  • P2B0011/003 Study Veracity Neuroscience

    Memphis, Tennessee, 38157

  • p2B001/003 Study site Memphis

    Memphis, Tennessee, 38163

  • P2B001/003 site Miami

    Miami, Florida, 33136

  • P2B001/003 Study site Nashville

    Nashville, Tennessee, 37232

  • P2B001/003 New York

    New York, New York, 10029

  • P2B001/003 Site Port Charlotte

    Port Charlotte, Florida, 33980

  • P2B001/003 Site Sarasota

    Sarasota, Florida, 34243

  • P2B001/003 Site Scottsdale

    Scottsdale, Arizona, 85258

  • P2B001/003 study site Scottsdale

    Scottsdale, Arizona, 85259

  • P2B001/003 site St. Louis

    St Louis, Missouri, 63110

  • P2B001 Study site Syracuse

    Syracuse, New York, 13210

  • P2B001/003 Site Tampa

    Tampa, Florida, 33613

  • P2B001/003 Site Toledo

    Toledo, Ohio, 43614

  • P2B001 Study Vernon

    Vernon, Connecticut, 06066

  • P2B001/003 study site west Bloomfield

    West Bloomfield, Michigan, 48322

  • P2B001/003 Study site Williamsville

    Williamsville, New York, 14221

  • P2B001/003 Site Winfield

    Winfield, Illinois, 60190

Other trials in United States

Germany15 sites

  • P2B001/003 Study site Berlin

    Berlin, 12163

  • P2B001/003 Study site Berlin

    Berlin, 12203

  • P2B001/003 Study site Bochum

    Bochum, North Rhine-Westphalia, 44791

  • P2B001/003 Study site Dresden

    Dresden, SaACHSEN, 01307

  • P2B001/003 Study site Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • P2B001/003 study site Gera Germany

    Gera, Thuringia, 07551

  • P2B001/003 Study site Gera

    Gera, Thuringia, 07551

  • P2B001/003 study site Haag

    Haag, Bavaria, 83527

  • P2B001/003 Study site Haag

    Haag, Bavaria

  • P2B001/003 Study site Hanau

    Hanau, Hesse, 63450

  • P2B001/003 study site Leipzig

    Leipzig, Saxony, 04103

  • P2B001/003 Study site München

    München, Bavaria, 81675

  • P2B001/003 site Munich

    Munich

  • P2B001/003 Study site Münster

    Münster, North Rhine-Westphalia, 48149

  • P2B001/003 study site Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Spain11 sites

  • P2B001/003 Study site Barcelona

    Barcelona, 08025

  • P2B001/003 Study site Vall d'Hebrón

    Barcelona, 08035

  • P2B001/003 Study site La Paz

    Madrid, S, 28046

  • P2B001/003 Study site Navarra Madrid

    Madrid, 28027

  • P2B001/003 study site Madrid

    Madrid, 28034

  • P2B001/003 Study site Madrid

    Madrid, 28040

  • P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)

    Madrid, 28938

  • P2B001/003 Study site Puerta de Hierro - Majadahonda

    Majadahonda, 28222

  • P2B001/003 study site Mostoles

    Móstoles, Madridid, 28938

  • P2B001/003 Study site Pamplona

    Pamplona, Navarre, 31008

  • P2B001/003 Study site Sant Cugat del Vallés

    Sant Cugat Del Vallés, Barcelona, 08190

Other trials in Spain

Canada1 site

  • P2B001/003 study site Toronto

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

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.

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.

Read the 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.

Being tested
P2B001 0.6/0.75 mg, Rasagiline 0.75 mg, Pramipexole 0.6 mg, Marketed Pramipexole ER
Keywords
Parkinson disease, early Parkinson's Disease, Parkinson's diagnosis, Parkinson's tretment, Parkinson's medications
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P2B001 0.6/0.75 mgDrug

    Also called P2B001 capsule

    Fixed low dose extended release combination capsule of pramipexole and rasagiline

  • Rasagiline 0.75 mgDrug

    Also called RAS 0.75

    Rasagiline 0.75 mg oral extended release capsule, component

  • Pramipexole 0.6 mgDrug

    Also called PPX 0.6

    Pramipexole 0.6 mg oral extended release capsule, component

  • Marketed Pramipexole ERDrug

    Also called PramiER

    Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet

Study groups in NCT03329508
Study groupRoleWhat they receive
P2B001 0.6/0.75 mgExperimentalFixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet
Receives: Drug: P2B001 0.6/0.75 mg
rasagiline 0.75mgExperimentalRasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
Receives: Drug: Rasagiline 0.75 mg
Pramipexole 0.6mgExperimentalPramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet
Receives: Drug: Pramipexole 0.6 mg
Pramipexole Extended ReleaseActive comparatorMarketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule
Receives: Drug: Marketed Pramipexole ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).

    Differences between 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).

    UPDRS- Unified Parkinson's Disease Rating Scale, minimum value is 0 points and maximum value is 160.

    High score mean worse outcome.

    Measured: baseline to week 12

Secondary outcomes (4)

  1. Change in Epworth Sleepiness Scale (ESS) Score.

    Differences between P2B 0.6/0.75 mg as compared to pramipexole ER tablets in the change of Epworth Sleepiness Scale (ESS) score.

    Scale is 0-24 , when 24 is worse outcome

    Measured: baseline to week 12

  2. Change From Baseline to Week 12 in Total UPDRS III Motor

    Differences between P2B 0.6/0.75 mg as compared to its individual components in the change of Motor UPDRS score (UPDRS Part III ).

    UPDRS- Unified Parkinson's Disease Rating Scale, part III motor . min is 0 and Max is 108 (Worse outcome)

    Measured: baseline to week 12

  3. Change From Baseline to Week 12 in Total UPDRS II ADL

    Differences between of P2B 0.6/0.75 mg as compared to its individual components in the change of ADL UPDRS score (UPDRS part II) Activity of daily Life UPDRS part II minimum is 0 point and max is 52 point (worse outcome)

    Measured: Baseline to week 12

  4. Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39

    The efficacy of P2B 0.6/0.75 mg as compared to Pramipexole ER tablet titrated to optimal dose.

    ADL PDQ39- Activity of daily life part in Parkinson's Disease Questionaries' 39 Score 0-100 when 100 is the worse outcome

    Measured: Baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start19 Jan 2018
  3. Primary completion23 Aug 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 arms
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03329508
Sponsor's protocol ID
P2B001/003
Status last verified
Jun 2022
First submitted
30 Oct 2017
Last updated
21 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing P2B001 0.6/0.75 mg, Rasagiline 0.75 mg and Pramipexole 0.6 mg in people with Parkinson Disease and Early Parkinson's Disease, run by Pharma Two B Ltd. at 72 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Germany, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03329508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT03329508 | AzTrials