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AzTrials

Parkinson's DiseasePhase 3NCT02615873

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

A Phase 3 study testing Accordion Pill™ Carbidopa/Levodopa in people with Parkinson's Disease, run by Intec Pharma Ltd. at 85 sites in 10 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 to 100 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Accordion Pill™ Carbidopa/Levodopa
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
85 sitesin 10 countries
Study dates
Jul 2016to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

85 sites in 10 countries.

85 sites in 10 countries

United States37 sites, 32 recruiting

  • Asheville Neurology Specialists

    Asheville, North Carolina, 28806

    Susan Woodard, 828-210-9311, research@ashneuro.com

    Not yet recruiting

  • University of Colorado Dept. of Neurology

    Aurora, Colorado, 80045

    Lauren Seeberger, MD, 303-724-2194, lauren.seeberger@ucdenver.edu

    Recruiting

  • North Texas Movement Disorders Institute

    Bedford, Texas, 76021

    Madhavi Thomas, MD, 214-432-7549, madhavithomas@ntmdi.com

    Not yet recruiting

  • University Alabama Hospital Neurology

    Birmingham, Alabama, 35233

    Joey Richardson, 205-934-0074, jhrichardson@uabmc.edu

    Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

    Stuart Isaacson, MD, 561-392-1818 ext. 6, isaacson@parkinsonscenter.org

    Recruiting

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

    Marie-Helene Saint-Hilaire, MD, 617-638-8456, neuromsh@bu.edu

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

    Danielle Helms, 843-792-8327, helmsda@musc.edu

    Not yet recruiting

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

    Terminated

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Christopher Goetz, MD, 312-563-2900, christopher_goetz@rush.edu

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0525

    Alberto Espay, MD, 513-558-4035, alberto.espay@uc.edu

    Not yet recruiting

  • David L. Kreitzman, MD., PC

    Commack, New York, 11725

    David Kreitzman, MD, 631-462-7774, pdmdcli@aol.com

    Recruiting

  • Michigan State University

    East Lansing, Michigan, 48824

    John Goudreau, MD, 517-432-9277, john.goudreau@hc.msu.edu

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

    Colin Sheedy, 248-957-8940, colin@questri.com

    Recruiting

  • Parkinson's Disease & Movement Disorders Center

    Fountain Valley, California, 92708

    Olivia Tong, 714-378-5033, olivia@pmdi.org

    Not yet recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Thyagarajan Subramanian, MD, 717-531-3828, tsubram@yahoo.com

    Recruiting

  • Baylor College of Medicine Department of Neurology

    Houston, Texas, 77030

    Joseph Jancovic, MD, 713-798-6556, josephj@bcm.edu

    Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

    Rajesh Pahwa, MD, 913-588-6782, rpahwa@kumc.edu

    Recruiting

  • Booth Garner Parkinson's Care Center

    Kirkland, Washington, 98034

    Carey Gonzales, 425-899-5374, clgonzales@evergreenhealth.com

    Recruiting

  • Dartmouth Hitchcock Neurology

    Lebanon, New Hampshire, 03756

    Charlotte Jeffreys, 603-650-3834, neurology@hitchcock.org

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Khashayar Dashtipour, MD, 909-558-2037, kdashtipour@llu.edu

    Not yet recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Danielle Feigenbaum, MD, 323-442-8029, feigenba@usc.edu

    Not yet recruiting

  • Collier Neurologic Specialists, LLC

    Naples, Florida, 34102

    John Campbell, MD, 239-434-0332, jcampbell@collierneurologic.com

    Not yet recruiting

  • Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences

    Nashville, Tennessee, 37232

    Kelly Harper, 615-322-2538, kelly.a.harper@vumc.org

    Recruiting

  • Fresco Institutute for Parkinson's and Movement Disorders

    New York, New York, 10016

    Daniella Mania, 646-501-9273, pdresearch@nyumc.org

    Not yet recruiting

  • Weill Cornell Medical College of Cornell University

    New York, New York, 10021

    Terminated

  • Bioclinica Research

    Orlando, Florida, 32806

    Jennifer Trotter, 407-210-1337, Jennifer.Trotter@bioclinica.com

    Not yet recruiting

  • SC3 Research

    Pasadena, California, 91105

    Anne Wilson, 626-250-2070, anne.wilson@neurosearch-usa.com

    Not yet recruiting

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

    Phoenix, Arizona, 85013

    Holly Shill, MD, 602-406-2014, holly.shill@dignityhealth.org

    Not yet recruiting

  • SC3 Research

    Reseda, California, 91335

    Anne Wilson, 626-250-2070, anne.wilson@neurosearch-usa.com

    Not yet recruiting

  • Atlantic Health System Hospital Corp.-Overlook Hospital

    Summit, New Jersey, 07902

    Terminated

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

    Terminated

  • Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

    Leigh Harrell, 813-396-0768

    Recruiting

  • University of Toledo

    Toledo, Ohio, 43614

    Stephanie Wilson

    Not yet recruiting

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

    Kevin Klos, MD, 918-392-4530, kevin.klos@mdcok.com

    Recruiting

  • Hartford HealthCare

    Vernon, Connecticut, 06066

    J. Antonelle de Marcaida, MD, 860-870-6385, joyantonelle.demarcaida@hhchealth.org

    Recruiting

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456

    Terminated

  • Henry Ford Hospital

    West Bloomfield, Michigan, 48322

    Victoria Churchill, 248-661-6540, vchurch1@hfhs.org

    Recruiting

Other trials in United States

Italy11 sites, 11 recruiting

  • Ospedale Generale Regionale Francesco Miulli

    Acquaviva delle Fonti, 70021

    Tamma Filippo, MD, +390803054843, filippo.tamma@miulli.it

    Not yet recruiting

  • Ospedali Riuniti di Ancona

    Ancona, 60126

    Maria Gabriella Ceravolo, MD, +390715964526, m.g.ceravolo@univpm.it

    Not yet recruiting

  • Casa di Cura Villa Margherita

    Arcugnano, 36057

    Giampietro Nordera, MD, +390444323271, giampietro.nordera@casadicuravillamargherita.it

    Not yet recruiting

  • Spedali Civili Di Brescia Azienda Ospedaliera

    Brescia, 25123

    Alessandro Padovani, MD, +390303384086, alessandro.padovani@unibs.it

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Giuseppe De Michele, MD, +390817463711, demichel@unina.it

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

    Ubaldo Bonuccelli, MD, +39050993604, u.bonuccelli@neuro.med.unipi.it

    Not yet recruiting

  • IRCCS San Raffaele Pisana

    Roma, 00163

    Fabrizio Stocchi, MD, +390666058456, fabrizio.stocchi@sanraffaele.it

    Not yet recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Annarita Bentivoglio, MD, +390630154325, aerrepuck@gmail.com

    Not yet recruiting

  • NCL Neurological Centre of Latium

    Roma, 00178

    Giuseppe Meco, MD, +393477323771, giuseppe.meco@uniroma1.it

    Not yet recruiting

  • Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84131

    Paolo Barone, MD, +39089969119, pbarone@unisa.it

    Marina Picillo, MD, +39089969119, picillo.marina@gmail.com

    Not yet recruiting

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

    Giorgio Bono, MD, +390332278427, giorgio.bono@asst-settelaghi.it

    Not yet recruiting

Other trials in Italy

Ukraine9 sites, 9 recruiting

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

    Cherkasy, 18009

    Olena Moroz, MD, +380931543688, enmoroz@mail.ru

    Not yet recruiting

  • Dnipropetrovsk medical academy MOH of Ukraine

    Dnipro

    Lyudmyla Dzyak, MD, +380562463126, dzyak_la@dsma.dp.ua

    Not yet recruiting

  • Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

    Kharkiv, 61068

    Nataliya Voloshyna, MD, +380577383141, prof.voloshinanp@mail.ru

    Not yet recruiting

  • Kharkiv regional clinical psychiatry hospital #3

    Kharkiv, 61068

    Andriy Dubenko, MD, +380577382181, adneuro@mail.ru

    Not yet recruiting

  • Lviv City Clinical Hospital

    Lviv, 79010

    Janosh Sanotskyy, MD, +380505889710, sanotsky@gmail.com

    Not yet recruiting

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

    Poltava, 36024

    Nataliya Lytvynenko, MD, +380532606578, neurology@mail.ru

    Not yet recruiting

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

    Vinnytsia, 21005

    Sergii Moskovko, MD, +380432354075, spmoskovko@gmail.com

    Not yet recruiting

  • Clinical Hospital #2

    Zaporozh’ye, 69600

    Natalia Tomakh, MD, +380617698157, tomakh.family@mail.ru

    Not yet recruiting

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporozh’ye, 69600

    Alla Cherkez, MD, +380679584590, neyrozokb@gmail.com

    Not yet recruiting

Other trials in Ukraine

Poland7 sites, 7 recruiting

  • Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED

    Częstochowa, 42-280

    Janusz Kapustecki, MD, +48343617816, januszkapustecki@poczta.onet.pl

    Not yet recruiting

  • NEURO-CARE Site Management Organization Gabriela Klodowska-Duda

    Katowice, 40-749

    Gabriela Klodowska-Duda, MD, 48323539359, gabriela.duda@neuro-care.pl

    Not yet recruiting

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-954

    Ilona Palka-Kisielowska, +48324940590, ikisielowska@medicapf.pl

    Not yet recruiting

  • Krakowska Akademia Neurologii Sp. z o. o.

    Krakow, 31-505

    Monika Rudzinska, MD, 48124269280, rudzinsk@neuro.cm-uj.krakow.pl

    Not yet recruiting

  • Gabinet Lekarski Prof. Andrzej Bogucki

    Lodz, 90-130

    Andrzej Bogucki, MD, +48426304373, andrzej.bogucki@umed.lodz.pl

    Not yet recruiting

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

    Anatol Mickielewicz, MD, +48228346336, amickielewicz@medicapf.pl

    Not yet recruiting

  • Centrum Medyczne Damiana Holding

    Warsaw, 02-777

    Piotr Janik, MD, +48225662222, pjanik@wum.edu.pl

    Recruiting

Other trials in Poland

Israel6 sites, 6 recruiting

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

    Haifa

    Ilana Schlesinger, MD, 97248542605, i_schles@rambam.health.gov.il

    Ilana Schlesinger, M.D

    Recruiting

  • Rambam Medical Center

    Haifa

    Ilana Schlesinger, MD, +97248542605, i_schles@rambam.health.gov.il

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Ruth Djaldetti, MD, +97239378219, ruthdjal@clalit.org.il

    Recruiting

  • Chaim Sheba Medical Center at Tel Hashomer

    Ramat Gan

    Sandra Elincx - Benizri, MD, +972542383678, sandra.benizri@sheba.health.gov.il

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Tanya Gurevich, MD, +972524266734, tanyag@tlvmc.gov.il

    Recruiting

  • TASMC

    Tel Aviv

    Y. Knaani, 972-3-6973061

    T. Gurevich, MD

    Recruiting

Other trials in Israel

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

    Oriol De Fabregues, MD, +34934894258, odfabregues@vhebron.net

    Not yet recruiting

  • Hospital Universitario La Princesa

    Madrid, 28006

    Lydia Lopez Manzanares, MD, +34915202416, lydialopez@hotmail.com

    Not yet recruiting

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28222

    Juan Jose Lopez Lozano, MD, +34630884348, jjlopezlozano@gmail.com

    Not yet recruiting

  • Hospital Sant Joan de Deu de Manresa

    Manresa, 08243

    Antonio Ugarte, MD, +34938742112, augarte@althaia.cat

    Not yet recruiting

Other trials in Spain

United Kingdom4 sites, 4 recruiting

  • Fairfield General Hospital

    Bury, BL9 7TD

    Jason Raw, MD, +4401617783868, raw.jason@pat.nhs.uk

    Not yet recruiting

  • Newcastle University Clinical Ageing Research

    Newcastle upon Tyne, NE4 5PL

    Nicola Pavese, MD, +441912081250, nicola.pavese@newcastle.ac.uk

    Not yet recruiting

  • Queens Medical Centre Nottingham, University Hospital

    Nottingham, NG7 2UH

    Jonathan Evans, MD, +4407957585975, jonathan.evans2@nuh.nhs.uk

    Not yet recruiting

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG

    Simon Ellis, MD, +44 (0) 1782 675393, simon.ellis@uhns.nhs.uk

    Not yet recruiting

Other trials in United Kingdom

Bulgaria3 sites, 3 recruiting

  • MHAT 'Sv.Pantaleymon - Pleven' OOD

    Pleven, 5800

    Plamen Petkov, MD, +359878885861, pn.petkov@abv.bg

    Not yet recruiting

  • Clinic for Neurology and Sleep Medicine

    Sofia, 1407

    Ivan Staikov, MD, +35924034000, ivanstaikov@hotmail.com

    Not yet recruiting

  • Clinic of Neurological Diseases

    Sofia, 1797

    Rosen Ikonomov, MD, +359888766461, drros@abv.bg

    Not yet recruiting

Other trials in Bulgaria

Germany3 sites, 3 recruiting

  • Neuroakademie Alzenau GbR

    Aschaffenburg, 63755

    Ali Safavi, MD, +496023993270, drsafavi@yahoo.com

    Not yet recruiting

  • Uniklinikum Carl-Gustav Carus an der TU Dresden

    Dresden, 01307

    Heinz Reichmann, MD, +493514583565, heinz.reichmann@mailbox.tu-dresden.de

    Not yet recruiting

  • Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar

    München, 81675

    Bernhard Haslinger, MD, +498941404606, haslinger@lrz.tu-muenchen.de

    Not yet recruiting

Other trials in Germany

Slovakia1 site, 1 recruiting

  • Konzílium

    Dubnica nad Váhom, Trenčín Region, 01841

    Magdaléna Perichtová, MD, +421424426231, perichtova.magda@mail.t-com.sk

    Recruiting

Other trials in Slovakia

About this study

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

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).

Read the 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.

Being tested
Accordion Pill™ Carbidopa/Levodopa
Keywords
Parkinson's Disease, Fluctuating Parkinson's Disease, Carbidopa, Levodopa, Accordion
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accordion Pill™ Carbidopa/LevodopaDrug

    Also called 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

Study groups in NCT02615873
Study groupRoleWhat they receive
AP CD/LDExperimentalAccordion 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
Receives: Drug: Accordion Pill™ Carbidopa/Levodopa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Unified Parkinson's Disease Rating Scale (UPDRS)

    Change from Baseline to End of Study (Week 53) in Parts I-IV

    Measured: base line ( week 1) to end of study ( week 53)

Secondary outcomes (2)

  1. Safety (Adverse Events, Safety laboratory, Vital signs)

    Adverse Events, Safety laboratory, Vital signs

    Measured: One Year

  2. Change in Parkinson's disease Questionnaire - 39 items (PDQ39).

    Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).

    Measured: Base line to end of study ( week 53)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2015 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02615873
Sponsor's protocol ID
IN 11 004 OLE
Status last verified
Dec 2017
First submitted
23 Nov 2015
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Accordion Pill™ Carbidopa/Levodopa in people with Parkinson's Disease, run by Intec Pharma Ltd. at 85 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Italy, Ukraine, Poland, Israel and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: base line ( week 1) to end of study ( week 53)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02615873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

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