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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AP CD/LD | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accordion Pill™ Carbidopa/Levodopa | 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 |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter LeWitt, MD | Henry Ford Hospital - West Bloomfield | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Alabama Hospital Neurology | Recruiting | Birmingham | Alabama | 35233 | United States |
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|
| Base line to end of study ( week 53) |
| Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center | Not yet recruiting | Phoenix | Arizona | 85013 | United States |
|
| Banner Sun Health Research Institute | Terminated | Sun City | Arizona | 85351 | United States |
| Parkinson's Disease & Movement Disorders Center | Not yet recruiting | Fountain Valley | California | 92708 | United States |
|
| Loma Linda University Medical Center | Not yet recruiting | Loma Linda | California | 92354 | United States |
|
| University of Southern California | Not yet recruiting | Los Angeles | California | 90033 | United States |
|
| SC3 Research | Not yet recruiting | Pasadena | California | 91105 | United States |
|
| SC3 Research | Not yet recruiting | Reseda | California | 91335 | United States |
|
| University of Colorado Dept. of Neurology | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Hartford HealthCare | Recruiting | Vernon | Connecticut | 06066 | United States |
|
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| Collier Neurologic Specialists, LLC | Not yet recruiting | Naples | Florida | 34102 | United States |
|
| Bioclinica Research | Not yet recruiting | Orlando | Florida | 32806 | United States |
|
| Parkinson's Disease and Movement Disorders Center | Recruiting | Tampa | Florida | 33613 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| The University of Kansas Hospital | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| Boston University School of Medicine | Recruiting | Boston | Massachusetts | 02118 | United States |
|
| Michigan State University | Recruiting | East Lansing | Michigan | 48824 | United States |
|
| Quest Research Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
|
| Henry Ford Hospital | Recruiting | West Bloomfield | Michigan | 48322 | United States |
|
| Dartmouth Hitchcock Neurology | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| Atlantic Health System Hospital Corp.-Overlook Hospital | Terminated | Summit | New Jersey | 07902 | United States |
| David L. Kreitzman, MD., PC | Recruiting | Commack | New York | 11725 | United States |
|
| Fresco Institutute for Parkinson's and Movement Disorders | Not yet recruiting | New York | New York | 10016 | United States |
|
| Weill Cornell Medical College of Cornell University | Terminated | New York | New York | 10021 | United States |
| Asheville Neurology Specialists | Not yet recruiting | Asheville | North Carolina | 28806 | United States |
|
| University of Cincinnati | Not yet recruiting | Cincinnati | Ohio | 45267-0525 | United States |
|
| University of Toledo | Not yet recruiting | Toledo | Ohio | 43614 | United States |
|
| The Movement Disorder Clinic of Oklahoma | Recruiting | Tulsa | Oklahoma | 74136 | United States |
|
| Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Medical University of South Carolina | Not yet recruiting | Charleston | South Carolina | 29403 | United States |
|
| Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| North Texas Movement Disorders Institute | Not yet recruiting | Bedford | Texas | 76021 | United States |
|
| Baylor College of Medicine Department of Neurology | Recruiting | Houston | Texas | 77030 | United States |
|
| Charlottesville Medical Research | Terminated | Charlottesville | Virginia | 22911 | United States |
| Sentara Neurology Specialists | Terminated | Virginia Beach | Virginia | 23456 | United States |
| Booth Garner Parkinson's Care Center | Recruiting | Kirkland | Washington | 98034 | United States |
|
| MHAT 'Sv.Pantaleymon - Pleven' OOD | Not yet recruiting | Pleven | 5800 | Bulgaria |
|
| Clinic for Neurology and Sleep Medicine | Not yet recruiting | Sofia | 1407 | Bulgaria |
|
| Clinic of Neurological Diseases | Not yet recruiting | Sofia | 1797 | Bulgaria |
|
| Neuroakademie Alzenau GbR | Not yet recruiting | Aschaffenburg | 63755 | Germany |
|
| Uniklinikum Carl-Gustav Carus an der TU Dresden | Not yet recruiting | Dresden | 01307 | Germany |
|
| Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar | Not yet recruiting | München | 81675 | Germany |
|
| Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease | Recruiting | Haifa | Israel |
|
| Rambam Medical Center | Recruiting | Haifa | Israel |
|
| Rabin Medical Center | Recruiting | Petah Tikva | 4941492 | Israel |
|
| Chaim Sheba Medical Center at Tel Hashomer | Recruiting | Ramat Gan | Israel |
|
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
|
| TASMC | Recruiting | Tel Aviv | Israel |
|
| Ospedale Generale Regionale Francesco Miulli | Not yet recruiting | Acquaviva delle Fonti | 70021 | Italy |
|
| Ospedali Riuniti di Ancona | Not yet recruiting | Ancona | 60126 | Italy |
|
| Casa di Cura Villa Margherita | Not yet recruiting | Arcugnano | 36057 | Italy |
|
| Spedali Civili Di Brescia Azienda Ospedaliera | Not yet recruiting | Brescia | 25123 | Italy |
|
| Azienda Ospedaliera Universitaria Federico II | Not yet recruiting | Naples | 80131 | Italy |
|
| Azienda Ospedaliero-Universitaria Pisana | Not yet recruiting | Pisa | 56126 | Italy |
|
| IRCCS San Raffaele Pisana | Not yet recruiting | Roma | 00163 | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli | Not yet recruiting | Roma | 00168 | Italy |
|
| NCL Neurological Centre of Latium | Not yet recruiting | Roma | 00178 | Italy |
|
| Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona | Not yet recruiting | Salerno | 84131 | Italy |
|
| Ospedale di Circolo e Fondazione Macchi | Not yet recruiting | Varese | 21100 | Italy |
|
| Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED | Not yet recruiting | Częstochowa | 42-280 | Poland |
|
| NEURO-CARE Site Management Organization Gabriela Klodowska-Duda | Not yet recruiting | Katowice | 40-749 | Poland |
|
| Centrum Medyczne Pratia Katowice I | Not yet recruiting | Katowice | 40-954 | Poland |
|
| Krakowska Akademia Neurologii Sp. z o. o. | Not yet recruiting | Krakow | 31-505 | Poland |
|
| Gabinet Lekarski Prof. Andrzej Bogucki | Not yet recruiting | Lodz | 90-130 | Poland |
|
| Centrum Medyczne Pratia Warszawa | Not yet recruiting | Warsaw | 01-868 | Poland |
|
| Centrum Medyczne Damiana Holding | Recruiting | Warsaw | 02-777 | Poland |
|
| Konzílium | Recruiting | Dubnica nad Váhom | Trenčín Region | 01841 | Slovakia |
|
| Hospital Universitari Vall D'Hebron | Not yet recruiting | Barcelona | 08035 | Spain |
|
| Hospital Universitario La Princesa | Not yet recruiting | Madrid | 28006 | Spain |
|
| Hospital Puerta de Hierro Majadahonda | Not yet recruiting | Majadahonda | 28222 | Spain |
|
| Hospital Sant Joan de Deu de Manresa | Not yet recruiting | Manresa | 08243 | Spain |
|
| Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability | Not yet recruiting | Cherkasy | 18009 | Ukraine |
|
| Dnipropetrovsk medical academy MOH of Ukraine | Not yet recruiting | Dnipro | Ukraine |
|
| Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine | Not yet recruiting | Kharkiv | 61068 | Ukraine |
|
| Kharkiv regional clinical psychiatry hospital #3 | Not yet recruiting | Kharkiv | 61068 | Ukraine |
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| Lviv City Clinical Hospital | Not yet recruiting | Lviv | 79010 | Ukraine |
|
| Regional Clinical Hospital n.a. N.V. Sklifosovskyi | Not yet recruiting | Poltava | 36024 | Ukraine |
|
| Municipal Institution Vinnytsia Regional Psychoneurological Hospital n. a. Acad. O.I. Yushchenko | Not yet recruiting | Vinnytsia | 21005 | Ukraine |
|
| Clinical Hospital #2 | Not yet recruiting | Zaporozh’ye | 69600 | Ukraine |
|
| Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Not yet recruiting | Zaporozh’ye | 69600 | Ukraine |
|
| Fairfield General Hospital | Not yet recruiting | Bury | BL9 7TD | United Kingdom |
|
| Newcastle University Clinical Ageing Research | Not yet recruiting | Newcastle upon Tyne | NE4 5PL | United Kingdom |
|
| Queens Medical Centre Nottingham, University Hospital | Not yet recruiting | Nottingham | NG7 2UH | United Kingdom |
|
| University Hospitals of North Midlands NHS Trust | Not yet recruiting | Stoke-on-Trent | ST4 6QG | United Kingdom |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
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