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A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Accordion Pill™ Carbidopa/Levodopa
Sponsored by
Intec Pharma Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Fluctuating Parkinson's Disease, Carbidopa, Levodopa, Accordion

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects who successfully completed the core study IN 11 004 and, in the opinion of the Investigator, would benefit from long-term treatment with AP-CD/LD
  2. Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria
  3. Has a good response to Levodopa in the opinion of the investigator
  4. Subjects able and willing to give written (signed and dated) informed consent to participate in the study

Exclusion Criteria:

  1. Participation in another clinical trial other than IN 11 004 and receipt of an investigational medication other than that administered in the context of IN 11 004 within 28 days prior to the planned start of treatment
  2. Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
  3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation
  4. If, in the opinion of the Investigator, subject should not participate in the study
  5. Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.

Sites / Locations

  • University Alabama Hospital NeurologyRecruiting
  • Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
  • Banner Sun Health Research Institute
  • Parkinson's Disease & Movement Disorders Center
  • Loma Linda University Medical Center
  • University of Southern California
  • SC3 Research
  • SC3 Research
  • University of Colorado Dept. of NeurologyRecruiting
  • Hartford HealthCareRecruiting
  • Parkinson's Disease and Movement Disorders Center of Boca RatonRecruiting
  • Collier Neurologic Specialists, LLC
  • Bioclinica Research
  • Parkinson's Disease and Movement Disorders CenterRecruiting
  • Rush University Medical CenterRecruiting
  • The University of Kansas HospitalRecruiting
  • Boston University School of MedicineRecruiting
  • Michigan State UniversityRecruiting
  • Quest Research InstituteRecruiting
  • Henry Ford HospitalRecruiting
  • Dartmouth Hitchcock NeurologyRecruiting
  • Atlantic Health System Hospital Corp.-Overlook Hospital
  • David L. Kreitzman, MD., PCRecruiting
  • Fresco Institutute for Parkinson's and Movement Disorders
  • Weill Cornell Medical College of Cornell University
  • Asheville Neurology Specialists
  • University of Cincinnati
  • University of Toledo
  • The Movement Disorder Clinic of OklahomaRecruiting
  • Penn State Milton S. Hershey Medical CenterRecruiting
  • Medical University of South Carolina
  • Vanderbilt University Medical Center Vanderbilt Clinical NeurosciencesRecruiting
  • North Texas Movement Disorders Institute
  • Baylor College of Medicine Department of NeurologyRecruiting
  • Charlottesville Medical Research
  • Sentara Neurology Specialists
  • Booth Garner Parkinson's Care CenterRecruiting
  • MHAT 'Sv.Pantaleymon - Pleven' OOD
  • Clinic for Neurology and Sleep Medicine
  • Clinic of Neurological Diseases
  • Neuroakademie Alzenau GbR
  • Uniklinikum Carl-Gustav Carus an der TU Dresden
  • Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar
  • Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's DiseaseRecruiting
  • Rambam Medical CenterRecruiting
  • Rabin Medical CenterRecruiting
  • Chaim Sheba Medical Center at Tel HashomerRecruiting
  • Tel Aviv Sourasky Medical CenterRecruiting
  • TASMCRecruiting
  • Ospedale Generale Regionale Francesco Miulli
  • Ospedali Riuniti di Ancona
  • Casa di Cura Villa Margherita
  • Spedali Civili Di Brescia Azienda Ospedaliera
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliero-Universitaria Pisana
  • IRCCS San Raffaele Pisana
  • Fondazione Policlinico Universitario Agostino Gemelli
  • NCL Neurological Centre of Latium
  • Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
  • Ospedale di Circolo e Fondazione Macchi
  • Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
  • NEURO-CARE Site Management Organization Gabriela Klodowska-Duda
  • Centrum Medyczne Pratia Katowice I
  • Krakowska Akademia Neurologii Sp. z o. o.
  • Gabinet Lekarski Prof. Andrzej Bogucki
  • Centrum Medyczne Pratia Warszawa
  • Centrum Medyczne Damiana HoldingRecruiting
  • KonzíliumRecruiting
  • Hospital Universitari Vall D'Hebron
  • Hospital Universitario La Princesa
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Sant Joan de Deu de Manresa
  • Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability
  • Dnipropetrovsk medical academy MOH of Ukraine
  • Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
  • Kharkiv regional clinical psychiatry hospital #3
  • Lviv City Clinical Hospital
  • Regional Clinical Hospital n.a. N.V. Sklifosovskyi
  • Municipal Institution Vinnytsia Regional Psychoneurological Hospital n. a. Acad. O.I. Yushchenko
  • Clinical Hospital #2
  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
  • Fairfield General Hospital
  • Newcastle University Clinical Ageing Research
  • Queens Medical Centre Nottingham, University Hospital
  • University Hospitals of North Midlands NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AP CD/LD

Arm Description

Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS)
Change from Baseline to End of Study (Week 53) in Parts I-IV

Secondary Outcome Measures

Safety (Adverse Events, Safety laboratory, Vital signs)
Adverse Events, Safety laboratory, Vital signs
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).

Full Information

First Posted
November 23, 2015
Last Updated
August 12, 2018
Sponsor
Intec Pharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02615873
Brief Title
A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004
Official Title
An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).
Detailed Description
This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004. After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed. Efficacy and safety will be assessed throughout the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Fluctuating Parkinson's Disease, Carbidopa, Levodopa, Accordion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AP CD/LD
Arm Type
Experimental
Arm Description
Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d
Intervention Type
Drug
Intervention Name(s)
Accordion Pill™ Carbidopa/Levodopa
Other Intervention Name(s)
AP CD/LD
Intervention Description
Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
Change from Baseline to End of Study (Week 53) in Parts I-IV
Time Frame
base line ( week 1) to end of study ( week 53)
Secondary Outcome Measure Information:
Title
Safety (Adverse Events, Safety laboratory, Vital signs)
Description
Adverse Events, Safety laboratory, Vital signs
Time Frame
One Year
Title
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
Description
Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).
Time Frame
Base line to end of study ( week 53)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who successfully completed the core study IN 11 004 and, in the opinion of the Investigator, would benefit from long-term treatment with AP-CD/LD Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria Has a good response to Levodopa in the opinion of the investigator Subjects able and willing to give written (signed and dated) informed consent to participate in the study Exclusion Criteria: Participation in another clinical trial other than IN 11 004 and receipt of an investigational medication other than that administered in the context of IN 11 004 within 28 days prior to the planned start of treatment Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation) Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation If, in the opinion of the Investigator, subject should not participate in the study Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter LeWitt, MD
Organizational Affiliation
Henry Ford Hospital - West Bloomfield
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Alabama Hospital Neurology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joey Richardson
Phone
205-934-0074
Email
jhrichardson@uabmc.edu
Facility Name
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Shill, MD
Phone
602-406-2014
Email
holly.shill@dignityhealth.org
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Terminated
Facility Name
Parkinson's Disease & Movement Disorders Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Tong
Phone
714-378-5033
Email
olivia@pmdi.org
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khashayar Dashtipour, MD
Phone
909-558-2037
Email
kdashtipour@llu.edu
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Feigenbaum, MD
Phone
323-442-8029
Email
feigenba@usc.edu
Facility Name
SC3 Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Wilson
Phone
626-250-2070
Email
anne.wilson@neurosearch-usa.com
Facility Name
SC3 Research
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Wilson
Phone
626-250-2070
Email
anne.wilson@neurosearch-usa.com
Facility Name
University of Colorado Dept. of Neurology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Seeberger, MD
Phone
303-724-2194
Email
lauren.seeberger@ucdenver.edu
Facility Name
Hartford HealthCare
City
Vernon
State/Province
Connecticut
ZIP/Postal Code
06066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Antonelle de Marcaida, MD
Phone
860-870-6385
Email
joyantonelle.demarcaida@hhchealth.org
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Isaacson, MD
Phone
561-392-1818
Ext
6
Email
isaacson@parkinsonscenter.org
Facility Name
Collier Neurologic Specialists, LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Campbell, MD
Phone
239-434-0332
Email
jcampbell@collierneurologic.com
Facility Name
Bioclinica Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Trotter
Phone
407-210-1337
Email
Jennifer.Trotter@bioclinica.com
Facility Name
Parkinson's Disease and Movement Disorders Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leigh Harrell
Phone
813-396-0768
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Goetz, MD
Phone
312-563-2900
Email
christopher_goetz@rush.edu
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajesh Pahwa, MD
Phone
913-588-6782
Email
rpahwa@kumc.edu
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Helene Saint-Hilaire, MD
Phone
617-638-8456
Email
neuromsh@bu.edu
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Goudreau, MD
Phone
517-432-9277
Email
john.goudreau@hc.msu.edu
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Sheedy
Phone
248-957-8940
Email
colin@questri.com
Facility Name
Henry Ford Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Churchill
Phone
248-661-6540
Email
vchurch1@hfhs.org
Facility Name
Dartmouth Hitchcock Neurology
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Jeffreys
Phone
603-650-3834
Email
neurology@hitchcock.org
Facility Name
Atlantic Health System Hospital Corp.-Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Individual Site Status
Terminated
Facility Name
David L. Kreitzman, MD., PC
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kreitzman, MD
Phone
631-462-7774
Email
pdmdcli@aol.com
Facility Name
Fresco Institutute for Parkinson's and Movement Disorders
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella Mania
Phone
646-501-9273
Email
pdresearch@nyumc.org
Facility Name
Weill Cornell Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Terminated
Facility Name
Asheville Neurology Specialists
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Woodard
Phone
828-210-9311
Email
research@ashneuro.com
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0525
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Espay, MD
Phone
513-558-4035
Email
alberto.espay@uc.edu
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Wilson
Facility Name
The Movement Disorder Clinic of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Klos, MD
Phone
918-392-4530
Email
kevin.klos@mdcok.com
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thyagarajan Subramanian, MD
Phone
717-531-3828
Email
tsubram@yahoo.com
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Helms
Phone
843-792-8327
Email
helmsda@musc.edu
Facility Name
Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Harper
Phone
615-322-2538
Email
kelly.a.harper@vumc.org
Facility Name
North Texas Movement Disorders Institute
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhavi Thomas, MD
Phone
214-432-7549
Email
madhavithomas@ntmdi.com
Facility Name
Baylor College of Medicine Department of Neurology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Jancovic, MD
Phone
713-798-6556
Email
josephj@bcm.edu
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Terminated
Facility Name
Sentara Neurology Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Individual Site Status
Terminated
Facility Name
Booth Garner Parkinson's Care Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carey Gonzales
Phone
425-899-5374
Email
clgonzales@evergreenhealth.com
Facility Name
MHAT 'Sv.Pantaleymon - Pleven' OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Plamen Petkov, MD
Phone
+359878885861
Email
pn.petkov@abv.bg
Facility Name
Clinic for Neurology and Sleep Medicine
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Staikov, MD
Phone
+35924034000
Email
ivanstaikov@hotmail.com
Facility Name
Clinic of Neurological Diseases
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosen Ikonomov, MD
Phone
+359888766461
Email
drros@abv.bg
Facility Name
Neuroakademie Alzenau GbR
City
Aschaffenburg
ZIP/Postal Code
63755
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Safavi, MD
Phone
+496023993270
Email
drsafavi@yahoo.com
Facility Name
Uniklinikum Carl-Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinz Reichmann, MD
Phone
+493514583565
Email
heinz.reichmann@mailbox.tu-dresden.de
Facility Name
Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Haslinger, MD
Phone
+498941404606
Email
haslinger@lrz.tu-muenchen.de
Facility Name
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Schlesinger, MD
Phone
97248542605
Email
i_schles@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ilana Schlesinger, M.D
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Schlesinger, MD
Phone
+97248542605
Email
i_schles@rambam.health.gov.il
Facility Name
Rabin Medical Center
City
Petah Tiqva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Djaldetti, MD
Phone
+97239378219
Email
ruthdjal@clalit.org.il
Facility Name
Chaim Sheba Medical Center at Tel Hashomer
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Elincx - Benizri, MD
Phone
+972542383678
Email
sandra.benizri@sheba.health.gov.il
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanya Gurevich, MD
Phone
+972524266734
Email
tanyag@tlvmc.gov.il
Facility Name
TASMC
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y. Knaani
Phone
972-3-6973061
First Name & Middle Initial & Last Name & Degree
T. Gurevich, MD
Facility Name
Ospedale Generale Regionale Francesco Miulli
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamma Filippo, MD
Phone
+390803054843
Email
filippo.tamma@miulli.it
Facility Name
Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Gabriella Ceravolo, MD
Phone
+390715964526
Email
m.g.ceravolo@univpm.it
Facility Name
Casa di Cura Villa Margherita
City
Arcugnano
ZIP/Postal Code
36057
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giampietro Nordera, MD
Phone
+390444323271
Email
giampietro.nordera@casadicuravillamargherita.it
Facility Name
Spedali Civili Di Brescia Azienda Ospedaliera
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Padovani, MD
Phone
+390303384086
Email
alessandro.padovani@unibs.it
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe De Michele, MD
Phone
+390817463711
Email
demichel@unina.it
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ubaldo Bonuccelli, MD
Phone
+39050993604
Email
u.bonuccelli@neuro.med.unipi.it
Facility Name
IRCCS San Raffaele Pisana
City
Roma
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi, MD
Phone
+390666058456
Email
fabrizio.stocchi@sanraffaele.it
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annarita Bentivoglio, MD
Phone
+390630154325
Email
aerrepuck@gmail.com
Facility Name
NCL Neurological Centre of Latium
City
Roma
ZIP/Postal Code
00178
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Meco, MD
Phone
+393477323771
Email
giuseppe.meco@uniroma1.it
Facility Name
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Barone, MD
Phone
+39089969119
Email
pbarone@unisa.it
First Name & Middle Initial & Last Name & Degree
Marina Picillo, MD
Phone
+39089969119
Email
picillo.marina@gmail.com
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgio Bono, MD
Phone
+390332278427
Email
giorgio.bono@asst-settelaghi.it
Facility Name
Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
City
Czestochowa
ZIP/Postal Code
42-280
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Kapustecki, MD
Phone
+48343617816
Email
januszkapustecki@poczta.onet.pl
Facility Name
NEURO-CARE Site Management Organization Gabriela Klodowska-Duda
City
Katowice
ZIP/Postal Code
40-749
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Klodowska-Duda, MD
Phone
48323539359
Email
gabriela.duda@neuro-care.pl
Facility Name
Centrum Medyczne Pratia Katowice I
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilona Palka-Kisielowska
Phone
+48324940590
Email
ikisielowska@medicapf.pl
Facility Name
Krakowska Akademia Neurologii Sp. z o. o.
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Rudzinska, MD
Phone
48124269280
Email
rudzinsk@neuro.cm-uj.krakow.pl
Facility Name
Gabinet Lekarski Prof. Andrzej Bogucki
City
Lodz
ZIP/Postal Code
90-130
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrzej Bogucki, MD
Phone
+48426304373
Email
andrzej.bogucki@umed.lodz.pl
Facility Name
Centrum Medyczne Pratia Warszawa
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatol Mickielewicz, MD
Phone
+48228346336
Email
amickielewicz@medicapf.pl
Facility Name
Centrum Medyczne Damiana Holding
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Janik, MD
Phone
+48225662222
Email
pjanik@wum.edu.pl
Facility Name
Konzílium
City
Dubnica nad Váhom
State/Province
Trencin
ZIP/Postal Code
01841
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdaléna Perichtová, MD
Phone
+421424426231
Email
perichtova.magda@mail.t-com.sk
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriol De Fabregues, MD
Phone
+34934894258
Email
odfabregues@vhebron.net
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lydia Lopez Manzanares, MD
Phone
+34915202416
Email
lydialopez@hotmail.com
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Jose Lopez Lozano, MD
Phone
+34630884348
Email
jjlopezlozano@gmail.com
Facility Name
Hospital Sant Joan de Deu de Manresa
City
Manresa
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Ugarte, MD
Phone
+34938742112
Email
augarte@althaia.cat
Facility Name
Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olena Moroz, MD
Phone
+380931543688
Email
enmoroz@mail.ru
Facility Name
Dnipropetrovsk medical academy MOH of Ukraine
City
Dnipropetrovs'k
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyudmyla Dzyak, MD
Phone
+380562463126
Email
dzyak_la@dsma.dp.ua
Facility Name
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya Voloshyna, MD
Phone
+380577383141
Email
prof.voloshinanp@mail.ru
Facility Name
Kharkiv regional clinical psychiatry hospital #3
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andriy Dubenko, MD
Phone
+380577382181
Email
adneuro@mail.ru
Facility Name
Lviv City Clinical Hospital
City
L'viv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janosh Sanotskyy, MD
Phone
+380505889710
Email
sanotsky@gmail.com
Facility Name
Regional Clinical Hospital n.a. N.V. Sklifosovskyi
City
Poltava
ZIP/Postal Code
36024
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya Lytvynenko, MD
Phone
+380532606578
Email
neurology@mail.ru
Facility Name
Municipal Institution Vinnytsia Regional Psychoneurological Hospital n. a. Acad. O.I. Yushchenko
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergii Moskovko, MD
Phone
+380432354075
Email
spmoskovko@gmail.com
Facility Name
Clinical Hospital #2
City
Zaporozh'ye
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Tomakh, MD
Phone
+380617698157
Email
tomakh.family@mail.ru
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporozh'ye
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alla Cherkez, MD
Phone
+380679584590
Email
neyrozokb@gmail.com
Facility Name
Fairfield General Hospital
City
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Raw, MD
Phone
+4401617783868
Email
raw.jason@pat.nhs.uk
Facility Name
Newcastle University Clinical Ageing Research
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Pavese, MD
Phone
+441912081250
Email
nicola.pavese@newcastle.ac.uk
Facility Name
Queens Medical Centre Nottingham, University Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Evans, MD
Phone
+4407957585975
Email
jonathan.evans2@nuh.nhs.uk
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Ellis, MD
Phone
+44 (0) 1782 675393
Email
simon.ellis@uhns.nhs.uk

12. IPD Sharing Statement

Learn more about this trial

A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

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