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

NCT ID: NCT02615873

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Accordion Pill™ Carbidopa/Levodopa

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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AP CD/LD

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intec Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter LeWitt, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital - West Bloomfield

Locations

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University Alabama Hospital Neurology

Birmingham, Alabama, United States

Site Status RECRUITING

Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Banner Sun Health Research Institute

Sun City, Arizona, United States

Site Status TERMINATED

Parkinson's Disease & Movement Disorders Center

Fountain Valley, California, United States

Site Status NOT_YET_RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status NOT_YET_RECRUITING

University of Southern California

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

SC3 Research

Pasadena, California, United States

Site Status NOT_YET_RECRUITING

SC3 Research

Reseda, California, United States

Site Status NOT_YET_RECRUITING

University of Colorado Dept. of Neurology

Aurora, Colorado, United States

Site Status RECRUITING

Hartford HealthCare

Vernon, Connecticut, United States

Site Status RECRUITING

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status RECRUITING

Collier Neurologic Specialists, LLC

Naples, Florida, United States

Site Status NOT_YET_RECRUITING

Bioclinica Research

Orlando, Florida, United States

Site Status NOT_YET_RECRUITING

Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

The University of Kansas Hospital

Kansas City, Kansas, United States

Site Status RECRUITING

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status RECRUITING

Michigan State University

East Lansing, Michigan, United States

Site Status RECRUITING

Quest Research Institute

Farmington Hills, Michigan, United States

Site Status RECRUITING

Henry Ford Hospital

West Bloomfield, Michigan, United States

Site Status RECRUITING

Dartmouth Hitchcock Neurology

Lebanon, New Hampshire, United States

Site Status RECRUITING

Atlantic Health System Hospital Corp.-Overlook Hospital

Summit, New Jersey, United States

Site Status TERMINATED

David L. Kreitzman, MD., PC

Commack, New York, United States

Site Status RECRUITING

Fresco Institutute for Parkinson's and Movement Disorders

New York, New York, United States

Site Status NOT_YET_RECRUITING

Weill Cornell Medical College of Cornell University

New York, New York, United States

Site Status TERMINATED

Asheville Neurology Specialists

Asheville, North Carolina, United States

Site Status NOT_YET_RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status NOT_YET_RECRUITING

University of Toledo

Toledo, Ohio, United States

Site Status NOT_YET_RECRUITING

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Site Status RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status NOT_YET_RECRUITING

Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences

Nashville, Tennessee, United States

Site Status RECRUITING

North Texas Movement Disorders Institute

Bedford, Texas, United States

Site Status NOT_YET_RECRUITING

Baylor College of Medicine Department of Neurology

Houston, Texas, United States

Site Status RECRUITING

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status TERMINATED

Sentara Neurology Specialists

Virginia Beach, Virginia, United States

Site Status TERMINATED

Booth Garner Parkinson's Care Center

Kirkland, Washington, United States

Site Status RECRUITING

MHAT 'Sv.Pantaleymon - Pleven' OOD

Pleven, , Bulgaria

Site Status NOT_YET_RECRUITING

Clinic for Neurology and Sleep Medicine

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

Clinic of Neurological Diseases

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

Neuroakademie Alzenau GbR

Aschaffenburg, , Germany

Site Status NOT_YET_RECRUITING

Uniklinikum Carl-Gustav Carus an der TU Dresden

Dresden, , Germany

Site Status NOT_YET_RECRUITING

Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar

München, , Germany

Site Status NOT_YET_RECRUITING

Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease

Haifa, , Israel

Site Status RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Chaim Sheba Medical Center at Tel Hashomer

Ramat Gan, , Israel

Site Status RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

TASMC

Tel Aviv, , Israel

Site Status RECRUITING

Ospedale Generale Regionale Francesco Miulli

Acquaviva delle Fonti, , Italy

Site Status NOT_YET_RECRUITING

Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status NOT_YET_RECRUITING

Casa di Cura Villa Margherita

Arcugnano, , Italy

Site Status NOT_YET_RECRUITING

Spedali Civili Di Brescia Azienda Ospedaliera

Brescia, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Site Status NOT_YET_RECRUITING

IRCCS San Raffaele Pisana

Roma, , Italy

Site Status NOT_YET_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status NOT_YET_RECRUITING

NCL Neurological Centre of Latium

Roma, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona

Salerno, , Italy

Site Status NOT_YET_RECRUITING

Ospedale di Circolo e Fondazione Macchi

Varese, , Italy

Site Status NOT_YET_RECRUITING

Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED

Częstochowa, , Poland

Site Status NOT_YET_RECRUITING

NEURO-CARE Site Management Organization Gabriela Klodowska-Duda

Katowice, , Poland

Site Status NOT_YET_RECRUITING

Centrum Medyczne Pratia Katowice I

Katowice, , Poland

Site Status NOT_YET_RECRUITING

Krakowska Akademia Neurologii Sp. z o. o.

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Gabinet Lekarski Prof. Andrzej Bogucki

Lodz, , Poland

Site Status NOT_YET_RECRUITING

Centrum Medyczne Pratia Warszawa

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Centrum Medyczne Damiana Holding

Warsaw, , Poland

Site Status RECRUITING

Konzílium

Dubnica nad Váhom, Trenčín Region, Slovakia

Site Status RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario La Princesa

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Puerta de Hierro Majadahonda

Majadahonda, , Spain

Site Status NOT_YET_RECRUITING

Hospital Sant Joan de Deu de Manresa

Manresa, , Spain

Site Status NOT_YET_RECRUITING

Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability

Cherkasy, , Ukraine

Site Status NOT_YET_RECRUITING

Dnipropetrovsk medical academy MOH of Ukraine

Dnipro, , Ukraine

Site Status NOT_YET_RECRUITING

Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

Kharkiv, , Ukraine

Site Status NOT_YET_RECRUITING

Kharkiv regional clinical psychiatry hospital #3

Kharkiv, , Ukraine

Site Status NOT_YET_RECRUITING

Lviv City Clinical Hospital

Lviv, , Ukraine

Site Status NOT_YET_RECRUITING

Regional Clinical Hospital n.a. N.V. Sklifosovskyi

Poltava, , Ukraine

Site Status NOT_YET_RECRUITING

Municipal Institution Vinnytsia Regional Psychoneurological Hospital n. a. Acad. O.I. Yushchenko

Vinnytsia, , Ukraine

Site Status NOT_YET_RECRUITING

Clinical Hospital #2

Zaporozh’ye, , Ukraine

Site Status NOT_YET_RECRUITING

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporozh’ye, , Ukraine

Site Status NOT_YET_RECRUITING

Fairfield General Hospital

Bury, , United Kingdom

Site Status NOT_YET_RECRUITING

Newcastle University Clinical Ageing Research

Newcastle upon Tyne, , United Kingdom

Site Status NOT_YET_RECRUITING

Queens Medical Centre Nottingham, University Hospital

Nottingham, , United Kingdom

Site Status NOT_YET_RECRUITING

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States Bulgaria Germany Israel Italy Poland Slovakia Spain Ukraine United Kingdom

Facility Contacts

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Joey Richardson

Role: primary

[email protected]
205-934-0074

Holly Shill, MD

Role: primary

[email protected]
602-406-2014

Olivia Tong

Role: primary

[email protected]
714-378-5033

Khashayar Dashtipour, MD

Role: primary

[email protected]
909-558-2037

Danielle Feigenbaum, MD

Role: primary

[email protected]
323-442-8029

Anne Wilson

Role: primary

[email protected]
626-250-2070

Anne Wilson

Role: primary

[email protected]
626-250-2070

Lauren Seeberger, MD

Role: primary

[email protected]
303-724-2194

J. Antonelle de Marcaida, MD

Role: primary

[email protected]
860-870-6385

Stuart Isaacson, MD

Role: primary

[email protected]
561-392-1818 ext. 6

John Campbell, MD

Role: primary

[email protected]
239-434-0332

Jennifer Trotter

Role: primary

[email protected]
407-210-1337

Leigh Harrell

Role: primary

813-396-0768

Christopher Goetz, MD

Role: primary

[email protected]
312-563-2900

Rajesh Pahwa, MD

Role: primary

[email protected]
913-588-6782

Marie-Helene Saint-Hilaire, MD

Role: primary

[email protected]
617-638-8456

John Goudreau, MD

Role: primary

[email protected]
517-432-9277

Colin Sheedy

Role: primary

[email protected]
248-957-8940

Victoria Churchill

Role: primary

[email protected]
248-661-6540

Charlotte Jeffreys

Role: primary

[email protected]
603-650-3834

David Kreitzman, MD

Role: primary

[email protected]
631-462-7774

Daniella Mania

Role: primary

[email protected]
646-501-9273

Susan Woodard

Role: primary

[email protected]
828-210-9311

Alberto Espay, MD

Role: primary

[email protected]
513-558-4035

Stephanie Wilson

Role: primary

Kevin Klos, MD

Role: primary

[email protected]
918-392-4530

Thyagarajan Subramanian, MD

Role: primary

[email protected]
717-531-3828

Danielle Helms

Role: primary

[email protected]
843-792-8327

Kelly Harper

Role: primary

[email protected]
615-322-2538

Madhavi Thomas, MD

Role: primary

[email protected]
214-432-7549

Joseph Jancovic, MD

Role: primary

[email protected]
713-798-6556

Carey Gonzales

Role: primary

[email protected]
425-899-5374

Plamen Petkov, MD

Role: primary

[email protected]
+359878885861

Ivan Staikov, MD

Role: primary

[email protected]
+35924034000

Rosen Ikonomov, MD

Role: primary

[email protected]
+359888766461

Ali Safavi, MD

Role: primary

[email protected]
+496023993270

Heinz Reichmann, MD

Role: primary

[email protected]
+493514583565

Bernhard Haslinger, MD

Role: primary

[email protected]
+498941404606

Ilana Schlesinger, MD

Role: primary

[email protected]
97248542605

Ilana Schlesinger, MD

Role: primary

[email protected]
+97248542605

Ruth Djaldetti, MD

Role: primary

[email protected]
+97239378219

Sandra Elincx - Benizri, MD

Role: primary

[email protected]
+972542383678

Tanya Gurevich, MD

Role: primary

[email protected]
+972524266734

Y. Knaani

Role: primary

972-3-6973061

Tamma Filippo, MD

Role: primary

[email protected]
+390803054843

Maria Gabriella Ceravolo, MD

Role: primary

[email protected]
+390715964526

Giampietro Nordera, MD

Role: primary

[email protected]
+390444323271

Alessandro Padovani, MD

Role: primary

[email protected]
+390303384086

Giuseppe De Michele, MD

Role: primary

[email protected]
+390817463711

Ubaldo Bonuccelli, MD

Role: primary

[email protected]
+39050993604

Fabrizio Stocchi, MD

Role: primary

[email protected]
+390666058456

Annarita Bentivoglio, MD

Role: primary

[email protected]
+390630154325

Giuseppe Meco, MD

Role: primary

[email protected]
+393477323771

Paolo Barone, MD

Role: primary

[email protected]
+39089969119

Marina Picillo, MD

Role: backup

[email protected]
+39089969119

Giorgio Bono, MD

Role: primary

[email protected]
+390332278427

Janusz Kapustecki, MD

Role: primary

[email protected]
+48343617816

Gabriela Klodowska-Duda, MD

Role: primary

[email protected]
48323539359

Ilona Palka-Kisielowska

Role: primary

[email protected]
+48324940590

Monika Rudzinska, MD

Role: primary

[email protected]
48124269280

Andrzej Bogucki, MD

Role: primary

[email protected]
+48426304373

Anatol Mickielewicz, MD

Role: primary

[email protected]
+48228346336

Piotr Janik, MD

Role: primary

[email protected]
+48225662222

Magdaléna Perichtová, MD

Role: primary

[email protected]
+421424426231

Oriol De Fabregues, MD

Role: primary

[email protected]
+34934894258

Lydia Lopez Manzanares, MD

Role: primary

[email protected]
+34915202416

Juan Jose Lopez Lozano, MD

Role: primary

[email protected]
+34630884348

Antonio Ugarte, MD

Role: primary

[email protected]
+34938742112

Olena Moroz, MD

Role: primary

[email protected]
+380931543688

Lyudmyla Dzyak, MD

Role: primary

[email protected]
+380562463126

Nataliya Voloshyna, MD

Role: primary

[email protected]
+380577383141

Andriy Dubenko, MD

Role: primary

[email protected]
+380577382181

Janosh Sanotskyy, MD

Role: primary

[email protected]
+380505889710

Nataliya Lytvynenko, MD

Role: primary

[email protected]
+380532606578

Sergii Moskovko, MD

Role: primary

[email protected]
+380432354075

Natalia Tomakh, MD

Role: primary

[email protected]
+380617698157

Alla Cherkez, MD

Role: primary

[email protected]
+380679584590

Jason Raw, MD

Role: primary

[email protected]
+4401617783868

Nicola Pavese, MD

Role: primary

[email protected]
+441912081250

Jonathan Evans, MD

Role: primary

[email protected]
+4407957585975

Simon Ellis, MD

Role: primary

[email protected]
+44 (0) 1782 675393

Other Identifiers

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IN 11 004 OLE

Identifier Type: -

Identifier Source: org_study_id

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