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

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

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).

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Accordion Pill™ Carbidopa/Levodopa

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.

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP CD/LD; 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	Drug: Accordion Pill™ Carbidopa/Levodopa; 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; Other Names: AP CD/LD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS)	Change from Baseline to End of Study (Week 53) in Parts I-IV	base line ( week 1) to end of study ( week 53)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Adverse Events, Safety laboratory, Vital signs)	Adverse Events, Safety laboratory, Vital signs	One Year
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).	Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).	Base line to end of study ( week 53)

Collaborators and Investigators

• Sponsor: Intec Pharma Ltd.
• Investigators: Principal Investigator: Peter LeWitt, MD, Henry Ford Hospital - West Bloomfield

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Levodopa; Carbidopa; Fluctuating Parkinson's Disease; Accordion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunologic Factors; Dopamine Agonists; Dopamine Agents; Adjuvants, Immunologic; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Levodopa; Carbidopa; Carbidopa, levodopa drug combination
• Other Study ID Numbers: IN 11 004 OLE