Clinical trial NCT02615873: A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Fluctuating Parkinson's Disease
Carbidopa
Levodopa
Accordion
Lead sponsor: Intec Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 460
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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