Back to resultsEfficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations (BouNDless)
Primary Purpose
Parkinson's Disease
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ND0612 Solution for SC infusion
Placebo for SC infusion
Carbidopa and Levodopa 25mg/100mg
Placebo for Carbidopa and Levodopa 25mg/100mg
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Male and female patients, aged ≥30 years.
- PD diagnosis consistent with the UK Brain Bank Criteria.
- Modified Hoehn & Yahr score ≤3 during ON.
- Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as confirmed by patient diary over 3 days.
- Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/DDI, e.g.,Rytary®) at a total daily dose of ≥400mg.
Exclusion Criteria:
- Atypical or secondary parkinsonism.
- Severe disabling dyskinesias, based on Investigator's discretion.
- Previous neurosurgery for PD.
- Use of duodenal levodopa infusion (LCIG)* or apomorphine infusion.
- Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
- Previous participation in ND0612 studies.
- History of significant skin conditions or disorders.
Sites / Locations
- Xenoscience
- University of Arkansas for Medical Sciences
- The Research Center of Southern California
- Collaborative Neuroscience Network
- Cedar- Sinai Medical Center Department of Neurology
- SC3 Research - Reseda
- University of California San Francisco
- Rocky Mountain Movement Disorders Center
- Hartford Healthcare Chase Family Movement Disorders Center
- Visionary Investigators Network
- Parkinsons Disease and Movement Disorders Center of Boca Raton
- University of Florida Norman Fixel Institute for Neurological Diseases
- Neurology Associates PA
- USF Parkinson's Disease and Movement Disorders Center
- Neurology One
- Emory University - Brain Health Center
- NeuroStudies
- Hawaii Pacific Neuroscience
- Rush University Medical Center
- Unity Point Health
- University of Kansas Medical Center
- University of Kentucky, Neurology and Movement Disorder
- Oschner Medical Center
- Beth Israel Deaconess Medical Center
- QUEST Research Institute
- Henry Ford West Bloomfield Hospital
- Lou Ruvo Center for Brain Health
- Rutgers-Robert Wood Johnson Medical School
- New York-Presbyterian Brooklyn Methodist Hospital
- Weill Cornell Medicine
- Mount Sinai Medical center Movement Disorders Center
- SUNY Upstate Medical University
- Asheville Neurology Specialists PA
- Duke University
- University of Cincinnati
- Cleveland Clinic
- Thomas Jefferson University
- Abington Neurological Associates LTD.
- Medical University of South Carolina
- Vanderbilt University Medical Center
- Neurology Consultants of Dallas
- University of Vermont Medical Center
- University of Virginia
- University of Wisconsin Madison
- Medical University Innsbruck
- CHU de Tivoli
- Neurologicka klinika Fakutni nemocnice sv. Anny v Brne
- NEUROHK s.r.o. - Policlinic Chocen
- Neurologicka klinika
- Axon Clinical s.r.o.
- Hopital Neurologique
- Hopital Gabriel Montpied
- Hopital de la Timone
- CHU Nantes-Hopital Laennec
- CHU de Nice Hpital Pasteur
- Chu Caremeau
- Hopital Purpan
- University of Pecs, Clinical Center
- Soroka University Medical Center
- Edith Wolfson Medical Center
- Hadassah Medical Center, Ein Kerem
- Galilee Medical center- Nahariya
- Rabin Medical Center, Beilinson Hospital
- Chaim Sheba Medical Center
- Tel Aviv Sourasky Medical Center
- Shamir Medical Center
- Casa di Cura Villa Margherita
- Centro Ricerca Parkinson San Raffaele Cassino
- University Chieti CeSI MET Clinical research center-CRC
- Ospedale di Grosseto, Azienda USL Toscana Sud Est
- Istituto Clinico Humanitas - IRCCS
- AOU University of Campania "Luigi Vanvitelli"
- IRCCS Fondazione C. Mondino
- Azienda Ospedaliero Universitaria - PO Santa Chiara
- IRCCS San Raffaele Pisana
- Policlinico Tor Vergata - UOSD Parkinson
- IRCCS Santa Lucia Foundation
- University of Amsterdam
- Krakowska Akademia Neurologii Sp. z o. o
- NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
- Neuro-Care SP z o. o.
- Oddział Neurologii ul. L. Kondratowicza 8
- Hospital Braga
- CNS - Campus Neurologico Senior
- Kazan State Medical University
- Federal Siberian Scientic Clinical Center of FMBA
- Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
- The first Saint-Petersburg State Medical University named after IP Pavlov
- Siberian State Medical University
- Clinical Center of Serbia
- Nemocnica akad. L. Derera
- Hospital General Universitario de Elche, Edificio principal
- Hospital Universitari de la Vall d'Hebron
- Hospital de La Santa Creu I Sant Pau
- Hospital Universitari General de Catalunya
- Hospital Universitari Mutua Terrassa
- Hospital Universitario de Burgos
- Complejo Hospitalario Ruber Juan Bravo
- Hospital Universitario La Princesa
- Hospital Universitario Gregorio Marañón
- Hospital Universitario Ramon y Cajal
- Hospital Clinico San Carlos
- Hospital Universitario Infanta Sofia
- Clinica Universidad de Navarra
- Hospital Policlinica de Guipuzkoax Policlinica Guipuzcoa
- Hospital Universitario Virgen del Rocío, Laboratorio 104.
- Hospital Universitario y Politcnico de La Fe
- Clinic "Dopomoga Plus"
- Institute of Gerontolgoy - Parkinsons disease Treatment Centre
- Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
- Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
- Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council
- King's College hospital
- St Georges University Hospital
- Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
- Clinical Ageing research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
Placebo for ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
Outcomes
Primary Outcome Measures
The change in daily ON time without troublesome dyskinesia
ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary
Secondary Outcome Measures
The change in daily OFF time
OFF time per patient diary
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04006210
Brief Title
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations
Acronym
BouNDless
Official Title
A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Study of the Efficacy, Safety, and Tolerability of Continuous SC ND0612 Infusion vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multi-center, randomized, double blind, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR LD/CD.
Subjects can continue to an optional open-label extension period for one year; To contact US site near you should go to: www.BouNDless-Study.com
Detailed Description
This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease experiencing motor fluctuations.
This study is comprised of 6 periods:
a Screening Period;
an open-label oral IR-LD/CD Adjustment Period.
an open-label ND0612 Conversion Period.
a randomized, double-blind, double-dummy, active-controlled Maintenance Period.
an optional open-label Treatment Extension; and
a Safety Follow-up Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded Site Rater, Blinded CRAs, active drugs and matching placebo are identical in their appearance.
Allocation
Randomized
Enrollment
381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Placebo for ND0612 SC infusion + placebo IR-LD/CD + active IR-LD/CD (Carbidopa Levodopa USP tabs 25mg/100mg), for 24 hours.
Intervention Type
Combination Product
Intervention Name(s)
ND0612 Solution for SC infusion
Intervention Description
Levodopa Carbidopa solution administered SC via infusion pump
Intervention Type
Combination Product
Intervention Name(s)
Placebo for SC infusion
Intervention Description
Placebo solution administered SC via infusion pump
Intervention Type
Drug
Intervention Name(s)
Carbidopa and Levodopa 25mg/100mg
Intervention Description
Encapsulated Carbidopa and Levodopa USP 25mg/100mg
Intervention Type
Drug
Intervention Name(s)
Placebo for Carbidopa and Levodopa 25mg/100mg
Intervention Description
Encapsulated Placebo for Carbidopa and Levodopa USP 25mg/100mg
Primary Outcome Measure Information:
Title
The change in daily ON time without troublesome dyskinesia
Description
ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary
Time Frame
Baseline to the end of DBDD Maintenance Period (12 weeks)
Secondary Outcome Measure Information:
Title
The change in daily OFF time
Description
OFF time per patient diary
Time Frame
Baseline to the end of DBDD Maintenance Period (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients, aged ≥30 years.
PD diagnosis consistent with the UK Brain Bank Criteria.
Modified Hoehn & Yahr score ≤3 during ON.
Average of ≥2.5 hours of OFF time (≥2 hours OFF every day) during waking hours as confirmed by patient diary over 3 days.
Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/DDI, e.g.,Rytary®) at a total daily dose of ≥400mg.
Exclusion Criteria:
Atypical or secondary parkinsonism.
Severe disabling dyskinesias, based on Investigator's discretion.
Previous neurosurgery for PD.
Use of duodenal levodopa infusion (LCIG)* or apomorphine infusion.
Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
Previous participation in ND0612 studies.
History of significant skin conditions or disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto J Espay, MD, MSc
Organizational Affiliation
University of Cincinnati OH, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olivier Rascol, MD, PhD
Organizational Affiliation
Toulouse University Hospital, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
The Research Center of Southern California
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Cedar- Sinai Medical Center Department of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048 -1804
Country
United States
Facility Name
SC3 Research - Reseda
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rocky Mountain Movement Disorders Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Hartford Healthcare Chase Family Movement Disorders Center
City
Vernon
State/Province
Connecticut
ZIP/Postal Code
06066
Country
United States
Facility Name
Visionary Investigators Network
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Parkinsons Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486-2359
Country
United States
Facility Name
University of Florida Norman Fixel Institute for Neurological Diseases
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Neurology Associates PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-4723
Country
United States
Facility Name
USF Parkinson's Disease and Movement Disorders Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Neurology One
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Emory University - Brain Health Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroStudies
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Unity Point Health
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky, Neurology and Movement Disorder
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Oschner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334-2980
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
899106
Country
United States
Facility Name
Rutgers-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York-Presbyterian Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical center Movement Disorders Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2306
Country
United States
Facility Name
Asheville Neurology Specialists PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806-2287
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Abington Neurological Associates LTD.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090-1749
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Neurology Consultants of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0816
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2281
Country
United States
Facility Name
Medical University Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
CHU de Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Neurologicka klinika Fakutni nemocnice sv. Anny v Brne
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
NEUROHK s.r.o. - Policlinic Chocen
City
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Neurologicka klinika
City
Prague
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Axon Clinical s.r.o.
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Hopital Neurologique
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hopital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Nantes-Hopital Laennec
City
Nantes
ZIP/Postal Code
44800
Country
France
Facility Name
CHU de Nice Hpital Pasteur
City
Nice
ZIP/Postal Code
6002
Country
France
Facility Name
Chu Caremeau
City
Nimes
ZIP/Postal Code
GARD 30000
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
University of Pecs, Clinical Center
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Soroka University Medical Center
City
Be'er Sheva
ZIP/Postal Code
85025
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
582000
Country
Israel
Facility Name
Hadassah Medical Center, Ein Kerem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Galilee Medical center- Nahariya
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Shamir Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Casa di Cura Villa Margherita
City
Arcugnano
ZIP/Postal Code
36057
Country
Italy
Facility Name
Centro Ricerca Parkinson San Raffaele Cassino
City
Cassino
ZIP/Postal Code
03043
Country
Italy
Facility Name
University Chieti CeSI MET Clinical research center-CRC
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ospedale di Grosseto, Azienda USL Toscana Sud Est
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Istituto Clinico Humanitas - IRCCS
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AOU University of Campania "Luigi Vanvitelli"
City
Naples
ZIP/Postal Code
80138
Country
Italy
Facility Name
IRCCS Fondazione C. Mondino
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria - PO Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
IRCCS San Raffaele Pisana
City
Roma
ZIP/Postal Code
RM 163
Country
Italy
Facility Name
Policlinico Tor Vergata - UOSD Parkinson
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
IRCCS Santa Lucia Foundation
City
Rome
ZIP/Postal Code
179
Country
Italy
Facility Name
University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Krakowska Akademia Neurologii Sp. z o. o
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
City
Lodz
ZIP/Postal Code
90-640
Country
Poland
Facility Name
Neuro-Care SP z o. o.
City
Siemianowice Śląskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Oddział Neurologii ul. L. Kondratowicza 8
City
Warsaw
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Hospital Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
CNS - Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
256-280
Country
Portugal
Facility Name
Kazan State Medical University
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Federal Siberian Scientic Clinical Center of FMBA
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
The first Saint-Petersburg State Medical University named after IP Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Nemocnica akad. L. Derera
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Hospital General Universitario de Elche, Edificio principal
City
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitari General de Catalunya
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitari Mutua Terrassa
City
Barcelona
ZIP/Postal Code
8222
Country
Spain
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Complejo Hospitalario Ruber Juan Bravo
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Infanta Sofia
City
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Policlinica de Guipuzkoax Policlinica Guipuzcoa
City
San Sebastian
ZIP/Postal Code
20009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío, Laboratorio 104.
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario y Politcnico de La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Clinic "Dopomoga Plus"
City
Kyiv
ZIP/Postal Code
04111
Country
Ukraine
Facility Name
Institute of Gerontolgoy - Parkinsons disease Treatment Centre
City
Kyiv
ZIP/Postal Code
4114
Country
Ukraine
Facility Name
Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council
City
Zaporozhye
ZIP/Postal Code
69065
Country
Ukraine
Facility Name
King's College hospital
City
London
ZIP/Postal Code
SE5 9RT
Country
United Kingdom
Facility Name
St Georges University Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Clinical Ageing research Unit
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral IR-LD/CD in Subjects With PD Experiencing Motor Fluctuations
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