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
1 other identifier
interventional
460
10 countries
85
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2016
Typical duration for phase_3
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 14, 2018
December 1, 2017
3.4 years
November 23, 2015
August 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety (Adverse Events, Safety laboratory, Vital signs)
One Year
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
Base line to end of study ( week 53)
Study Arms (1)
AP CD/LD
EXPERIMENTALAccordion 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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
University Alabama Hospital Neurology
Birmingham, Alabama, 35233, United States
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, 85013, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Parkinson's Disease & Movement Disorders Center
Fountain Valley, California, 92708, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
SC3 Research
Pasadena, California, 91105, United States
SC3 Research
Reseda, California, 91335, United States
University of Colorado Dept. of Neurology
Aurora, Colorado, 80045, United States
Hartford HealthCare
Vernon, Connecticut, 06066, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Collier Neurologic Specialists, LLC
Naples, Florida, 34102, United States
Bioclinica Research
Orlando, Florida, 32806, United States
Parkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Henry Ford Hospital
West Bloomfield, Michigan, 48322, United States
Dartmouth Hitchcock Neurology
Lebanon, New Hampshire, 03756, United States
Atlantic Health System Hospital Corp.-Overlook Hospital
Summit, New Jersey, 07902, United States
David L. Kreitzman, MD., PC
Commack, New York, 11725, United States
Fresco Institutute for Parkinson's and Movement Disorders
New York, New York, 10016, United States
Weill Cornell Medical College of Cornell University
New York, New York, 10021, United States
Asheville Neurology Specialists
Asheville, North Carolina, 28806, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0525, United States
University of Toledo
Toledo, Ohio, 43614, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences
Nashville, Tennessee, 37232, United States
North Texas Movement Disorders Institute
Bedford, Texas, 76021, United States
Baylor College of Medicine Department of Neurology
Houston, Texas, 77030, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456, United States
Booth Garner Parkinson's Care Center
Kirkland, Washington, 98034, United States
MHAT 'Sv.Pantaleymon - Pleven' OOD
Pleven, 5800, Bulgaria
Clinic for Neurology and Sleep Medicine
Sofia, 1407, Bulgaria
Clinic of Neurological Diseases
Sofia, 1797, Bulgaria
Neuroakademie Alzenau GbR
Aschaffenburg, 63755, Germany
Uniklinikum Carl-Gustav Carus an der TU Dresden
Dresden, 01307, Germany
Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar
München, 81675, Germany
Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center at Tel Hashomer
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
TASMC
Tel Aviv, Israel
Ospedale Generale Regionale Francesco Miulli
Acquaviva delle Fonti, 70021, Italy
Ospedali Riuniti di Ancona
Ancona, 60126, Italy
Casa di Cura Villa Margherita
Arcugnano, 36057, Italy
Spedali Civili Di Brescia Azienda Ospedaliera
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126, Italy
IRCCS San Raffaele Pisana
Roma, 00163, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
NCL Neurological Centre of Latium
Roma, 00178, Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
Salerno, 84131, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
Częstochowa, 42-280, Poland
NEURO-CARE Site Management Organization Gabriela Klodowska-Duda
Katowice, 40-749, Poland
Centrum Medyczne Pratia Katowice I
Katowice, 40-954, Poland
Krakowska Akademia Neurologii Sp. z o. o.
Krakow, 31-505, Poland
Gabinet Lekarski Prof. Andrzej Bogucki
Lodz, 90-130, Poland
Centrum Medyczne Pratia Warszawa
Warsaw, 01-868, Poland
Centrum Medyczne Damiana Holding
Warsaw, 02-777, Poland
Konzílium
Dubnica nad Váhom, Trenčín Region, 01841, Slovakia
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Sant Joan de Deu de Manresa
Manresa, 08243, Spain
Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability
Cherkasy, 18009, Ukraine
Dnipropetrovsk medical academy MOH of Ukraine
Dnipro, Ukraine
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, 61068, Ukraine
Kharkiv regional clinical psychiatry hospital #3
Kharkiv, 61068, Ukraine
Lviv City Clinical Hospital
Lviv, 79010, Ukraine
Regional Clinical Hospital n.a. N.V. Sklifosovskyi
Poltava, 36024, Ukraine
Municipal Institution Vinnytsia Regional Psychoneurological Hospital n. a. Acad. O.I. Yushchenko
Vinnytsia, 21005, Ukraine
Clinical Hospital #2
Zaporozh’ye, 69600, Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporozh’ye, 69600, Ukraine
Fairfield General Hospital
Bury, BL9 7TD, United Kingdom
Newcastle University Clinical Ageing Research
Newcastle upon Tyne, NE4 5PL, United Kingdom
Queens Medical Centre Nottingham, University Hospital
Nottingham, NG7 2UH, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter LeWitt, MD
Henry Ford Hospital - West Bloomfield
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 26, 2015
Study Start
July 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 14, 2018
Record last verified: 2017-12