search
Back to results

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

Primary Purpose

Parkinson Disease, Early Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
P2B001 0.6/0.75 mg
Rasagiline 0.75 mg
Pramipexole 0.6 mg
Marketed Pramipexole ER
Sponsored by
Pharma Two B Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, early Parkinson's Disease, Parkinson's diagnosis, Parkinson's tretment, Parkinson's medications

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • P2B001/003 Site Scottsdale
  • P2B001/003 study site Scottsdale
  • P2B001/003 Study site little Rock
  • P2B001 site Los Angeles
  • P2B001 Study site Englewood,
  • P2B001 Study Vernon
  • P2B001/003 site Boca Raton
  • P2B001/003 Site Boca Raton
  • P2B001/003 study site Jacksonville
  • P2B001/003 site Miami
  • P2B001/003 Site Port Charlotte
  • P2B001/003 Site Sarasota
  • P2B001/003 Site Tampa
  • P2B001/003 Site Augusta
  • P2B001/003 study site Honolulu
  • P2B001/003 site Chicago
  • P2B001/003 Site Winfield
  • P2B001/003 site Kansas City
  • P2B001/003 Site Lexington
  • P2B001/003 study site Boston
  • P2B001/003 Site East Lansing
  • P2B001/003 study site west Bloomfield
  • P2B001/003 Site Golden Valley
  • P2B001/003 site St. Louis
  • P2B001/003 study site New Hampshire
  • P2B001/003 Study site Camden
  • P2B001 Study site Edison
  • P2B001/003 Study site Albuquerque
  • P2B001/003 Study site Brooklyn
  • P2B001/003 Site Commack
  • P2B001/003 New York
  • P2B001 Study site Syracuse
  • P2B001/003 Study site Williamsville
  • P2B001/003 Site Asheville
  • P2B001 study site Cincinnati
  • P2B001/003 Site Toledo
  • P2B001/003 Study site Hershey
  • P2B001/003 Greenville
  • P2B0011/003 Study Veracity Neuroscience
  • p2B001/003 Study site Memphis
  • P2B001/003 Study site Nashville
  • P2B001/003 Site Dallas
  • P2B001/003 Study site Alexandria
  • P2B001/003
  • P2B001/003 Site Kirkland
  • P2B001/003 study site Toronto
  • P2B001/003 study site Ulm
  • P2B001/003 Study site Freiburg
  • P2B001/003 study site Haag
  • P2B001/003 Study site Haag
  • P2B001/003 Study site München
  • P2B001/003 Study site Hanau
  • P2B001/003 Study site Bochum
  • P2B001/003 Study site Münster
  • P2B001/003 Study site Dresden
  • P2B001/003 study site Leipzig
  • P2B001/003 study site Gera Germany
  • P2B001/003 Study site Gera
  • P2B001/003 Study site Berlin
  • P2B001/003 Study site Berlin
  • P2B001/003 site Munich
  • P2B001/003 Study site Sant Cugat del Vallés
  • P2B001/003 study site Mostoles
  • P2B001/003 Study site Pamplona
  • P2B001/003 Study site La Paz
  • P2B001/003 Study site Barcelona
  • P2B001/003 Study site Vall d'Hebrón
  • P2B001/003 Study site Navarra Madrid
  • P2B001/003 study site Madrid
  • P2B001/003 Study site Madrid
  • P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)
  • P2B001/003 Study site Puerta de Hierro - Majadahonda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

P2B001 0.6/0.75 mg

rasagiline 0.75mg

Pramipexole 0.6mg

Pramipexole Extended Release

Arm Description

Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet

Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet

Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet

Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule

Outcomes

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).
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.

Secondary Outcome Measures

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
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)
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)
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

Full Information

First Posted
October 30, 2017
Last Updated
March 15, 2023
Sponsor
Pharma Two B Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03329508
Brief Title
A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
August 23, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharma Two B Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Early Parkinson's Disease
Keywords
Parkinson disease, early Parkinson's Disease, Parkinson's diagnosis, Parkinson's tretment, Parkinson's medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
4 arms
Masking
ParticipantCare ProviderInvestigator
Masking Description
double blind study
Allocation
Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P2B001 0.6/0.75 mg
Arm Type
Experimental
Arm Description
Fixed dose combination once daily capsule of pramipexole 0.6mg and rasagiline 0.75mg, + matching placebo tablet
Arm Title
rasagiline 0.75mg
Arm Type
Experimental
Arm Description
Rasagiline 0.75mg Once daily capsule, component of P2B001, + matching placebo tablet
Arm Title
Pramipexole 0.6mg
Arm Type
Experimental
Arm Description
Pramipexole 0.6mg once daily capsule, component of P2B001 + matching placebo tablet
Arm Title
Pramipexole Extended Release
Arm Type
Active Comparator
Arm Description
Marketed pramipexole ER tablet titrated to optimal dose of 1.5, 3.0 or 4.5mg + matching placebo capsule
Intervention Type
Drug
Intervention Name(s)
P2B001 0.6/0.75 mg
Other Intervention Name(s)
P2B001 capsule
Intervention Description
Fixed low dose extended release combination capsule of pramipexole and rasagiline
Intervention Type
Drug
Intervention Name(s)
Rasagiline 0.75 mg
Other Intervention Name(s)
RAS 0.75
Intervention Description
Rasagiline 0.75 mg oral extended release capsule, component
Intervention Type
Drug
Intervention Name(s)
Pramipexole 0.6 mg
Other Intervention Name(s)
PPX 0.6
Intervention Description
Pramipexole 0.6 mg oral extended release capsule, component
Intervention Type
Drug
Intervention Name(s)
Marketed Pramipexole ER
Other Intervention Name(s)
PramiER
Intervention Description
Marketed Pramipexole ER titrated to optimal dose of 1.5, 3 or 4.5 mg tablet
Primary Outcome Measure Information:
Title
Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score (Defined as Sum of Parts II and III, Scores (0-160).
Description
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.
Time Frame
baseline to week 12
Secondary Outcome Measure Information:
Title
Change in Epworth Sleepiness Scale (ESS) Score.
Description
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
Time Frame
baseline to week 12
Title
Change From Baseline to Week 12 in Total UPDRS III Motor
Description
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)
Time Frame
baseline to week 12
Title
Change From Baseline to Week 12 in Total UPDRS II ADL
Description
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)
Time Frame
Baseline to week 12
Title
Change From Baseline to End of Week 12 Visit in ADL Subscale of PDQ39
Description
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
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pninit Litman
Organizational Affiliation
Pharma2b LTD
Official's Role
Study Director
Facility Information:
Facility Name
P2B001/003 Site Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
P2B001/003 study site Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
P2B001/003 Study site little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
P2B001 site Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
P2B001 Study site Englewood,
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
P2B001 Study Vernon
City
Vernon
State/Province
Connecticut
ZIP/Postal Code
06066
Country
United States
Facility Name
P2B001/003 site Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
P2B001/003 Site Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
P2B001/003 study site Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
P2B001/003 site Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
P2B001/003 Site Port Charlotte
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
P2B001/003 Site Sarasota
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
P2B001/003 Site Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
P2B001/003 Site Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
P2B001/003 study site Honolulu
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
P2B001/003 site Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
P2B001/003 Site Winfield
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
P2B001/003 site Kansas City
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
P2B001/003 Site Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
P2B001/003 study site Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
P2B001/003 Site East Lansing
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
P2B001/003 study site west Bloomfield
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
P2B001/003 Site Golden Valley
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
P2B001/003 site St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
P2B001/003 study site New Hampshire
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
P2B001/003 Study site Camden
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
P2B001 Study site Edison
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
P2B001/003 Study site Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
P2B001/003 Study site Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
P2B001/003 Site Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
P2B001/003 New York
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
P2B001 Study site Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
P2B001/003 Study site Williamsville
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
P2B001/003 Site Asheville
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
P2B001 study site Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
P2B001/003 Site Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
P2B001/003 Study site Hershey
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
P2B001/003 Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
P2B0011/003 Study Veracity Neuroscience
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
Facility Name
p2B001/003 Study site Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
P2B001/003 Study site Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
P2B001/003 Site Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
P2B001/003 Study site Alexandria
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22311
Country
United States
Facility Name
P2B001/003
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
P2B001/003 Site Kirkland
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
P2B001/003 study site Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
P2B001/003 study site Ulm
City
Ulm
State/Province
Baden-wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
P2B001/003 Study site Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
P2B001/003 study site Haag
City
Haag
State/Province
Bayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
P2B001/003 Study site Haag
City
Haag
State/Province
Bayern
Country
Germany
Facility Name
P2B001/003 Study site München
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
P2B001/003 Study site Hanau
City
Hanau
State/Province
Hessen
ZIP/Postal Code
63450
Country
Germany
Facility Name
P2B001/003 Study site Bochum
City
Bochum
State/Province
Nordrhein-westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
P2B001/003 Study site Münster
City
Münster
State/Province
Nordrhein-westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
P2B001/003 Study site Dresden
City
Dresden
State/Province
SaACHSEN
ZIP/Postal Code
01307
Country
Germany
Facility Name
P2B001/003 study site Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
P2B001/003 study site Gera Germany
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07551
Country
Germany
Facility Name
P2B001/003 Study site Gera
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07551
Country
Germany
Facility Name
P2B001/003 Study site Berlin
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
P2B001/003 Study site Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
P2B001/003 site Munich
City
Munich
Country
Germany
Facility Name
P2B001/003 Study site Sant Cugat del Vallés
City
Sant Cugat del Vallés
State/Province
Barcelona
ZIP/Postal Code
08190
Country
Spain
Facility Name
P2B001/003 study site Mostoles
City
Mostoles
State/Province
Madridid
ZIP/Postal Code
28938
Country
Spain
Facility Name
P2B001/003 Study site Pamplona
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
P2B001/003 Study site La Paz
City
Madrid
State/Province
S
ZIP/Postal Code
28046
Country
Spain
Facility Name
P2B001/003 Study site Barcelona
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
P2B001/003 Study site Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
P2B001/003 Study site Navarra Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
P2B001/003 study site Madrid
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
P2B001/003 Study site Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
P2B0011/003 Study site HM Centro Integral de Neurociencias (CINAC)
City
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
P2B001/003 Study site Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs