A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004
- Conditions
- Parkinson's Disease
- Interventions
- Drug: Accordion Pill™ Carbidopa/Levodopa
- Registration Number
- NCT02615873
- Lead Sponsor
- Intec Pharma Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 460
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AP CD/LD 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
- Primary Outcome Measures
Name Time Method Unified Parkinson's Disease Rating Scale (UPDRS) base line ( week 1) to end of study ( week 53) Change from Baseline to End of Study (Week 53) in Parts I-IV
- Secondary Outcome Measures
Name Time Method Safety (Adverse Events, Safety laboratory, Vital signs) One Year Adverse Events, Safety laboratory, Vital signs
Change in Parkinson's disease Questionnaire - 39 items (PDQ39). Base line to end of study ( week 53) Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).
Trial Locations
- Locations (84)
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Parkinson's Disease & Movement Disorders Center
🇺🇸Fountain Valley, California, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
SC3 Research
🇺🇸Reseda, California, United States
The University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Atlantic Health System Hospital Corp.-Overlook Hospital
🇺🇸Summit, New Jersey, United States
Henry Ford Hospital
🇺🇸West Bloomfield, Michigan, United States
Dartmouth Hitchcock Neurology
🇺🇸Lebanon, New Hampshire, United States
North Texas Movement Disorders Institute
🇺🇸Bedford, Texas, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
MHAT 'Sv.Pantaleymon - Pleven' OOD
🇧🇬Pleven, Bulgaria
Clinic of Neurological Diseases
🇧🇬Sofia, Bulgaria
Uniklinikum Carl-Gustav Carus an der TU Dresden
🇩🇪Dresden, Germany
Chaim Sheba Medical Center at Tel Hashomer
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
TASMC
🇮🇱Tel Aviv, Israel
Spedali Civili Di Brescia Azienda Ospedaliera
🇮🇹Brescia, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
NEURO-CARE Site Management Organization Gabriela Klodowska-Duda
🇵🇱Katowice, Poland
NCL Neurological Centre of Latium
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
🇮🇹Salerno, Italy
Gabinet Lekarski Prof. Andrzej Bogucki
🇵🇱Lodz, Poland
Centrum Medyczne Pratia Warszawa
🇵🇱Warszawa, Poland
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, United Kingdom
Fairfield General Hospital
🇬🇧Bury, United Kingdom
Newcastle University Clinical Ageing Research
🇬🇧Newcastle upon Tyne, United Kingdom
Queens Medical Centre Nottingham, University Hospital
🇬🇧Nottingham, United Kingdom
Rabin Medical Center
🇮🇱Petah Tiqva, Israel
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Hartford HealthCare
🇺🇸Vernon, Connecticut, United States
Collier Neurologic Specialists, LLC
🇺🇸Naples, Florida, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
David L. Kreitzman, MD., PC
🇺🇸Commack, New York, United States
Fresco Institutute for Parkinson's and Movement Disorders
🇺🇸New York, New York, United States
Weill Cornell Medical College of Cornell University
🇺🇸New York, New York, United States
University of Toledo
🇺🇸Toledo, Ohio, United States
Sentara Neurology Specialists
🇺🇸Virginia Beach, Virginia, United States
Booth Garner Parkinson's Care Center
🇺🇸Kirkland, Washington, United States
Clinic for Neurology and Sleep Medicine
🇧🇬Sofia, Bulgaria
Neuroakademie Alzenau GbR
🇩🇪Aschaffenburg, Germany
Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar
🇩🇪Munchen, Germany
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
🇮🇱Haifa, Israel
Rambam Medical Center
🇮🇱Haifa, Israel
Ospedale Generale Regionale Francesco Miulli
🇮🇹Acquaviva delle Fonti, Italy
Casa di Cura Villa Margherita
🇮🇹Arcugnano, Italy
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
IRCCS San Raffaele Pisana
🇮🇹Roma, Italy
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Konzílium
🇸🇰Dubnica nad Váhom, Trencin, Slovakia
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital Sant Joan de Deu de Manresa
🇪🇸Manresa, Spain
Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability
🇺🇦Cherkasy, Ukraine
Asheville Neurology Specialists
🇺🇸Asheville, North Carolina, United States
Kharkiv regional clinical psychiatry hospital #3
🇺🇦Kharkiv, Ukraine
Lviv City Clinical Hospital
🇺🇦L'viv, Ukraine
Dnipropetrovsk medical academy MOH of Ukraine
🇺🇦Dnipropetrovs'k, Ukraine
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
🇺🇦Kharkiv, Ukraine
Regional Clinical Hospital n.a. N.V. Sklifosovskyi
🇺🇦Poltava, Ukraine
Municipal Institution Vinnytsia Regional Psychoneurological Hospital n. a. Acad. O.I. Yushchenko
🇺🇦Vinnytsya, Ukraine
Clinical Hospital #2
🇺🇦Zaporozh'ye, Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
🇺🇦Zaporozh'ye, Ukraine
Parkinson's Disease and Movement Disorders Center
🇺🇸Tampa, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University Alabama Hospital Neurology
🇺🇸Birmingham, Alabama, United States
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
🇺🇸Phoenix, Arizona, United States
Bioclinica Research
🇺🇸Orlando, Florida, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of Colorado Dept. of Neurology
🇺🇸Aurora, Colorado, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine Department of Neurology
🇺🇸Houston, Texas, United States
Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
🇵🇱Czestochowa, Poland
Centrum Medyczne Pratia Katowice I
🇵🇱Katowice, Poland
Krakowska Akademia Neurologii Sp. z o. o.
🇵🇱Krakow, Poland
Centrum Medyczne Damiana Holding
🇵🇱Warszawa, Poland