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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02615873
• Other study ID #: IN 11 004 OLE
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Intec Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Bulgaria	MHAT 'Sv.Pantaleymon - Pleven' OOD	Pleven
Bulgaria	Clinic for Neurology and Sleep Medicine	Sofia
Bulgaria	Clinic of Neurological Diseases	Sofia
Germany	Neuroakademie Alzenau GbR	Aschaffenburg
Germany	Uniklinikum Carl-Gustav Carus an der TU Dresden	Dresden
Germany	Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar	Munchen
Israel	Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Rabin Medical Center	Petah Tiqva
Israel	Chaim Sheba Medical Center at Tel Hashomer	Ramat Gan
Israel	TASMC	Tel Aviv
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Ospedale Generale Regionale Francesco Miulli	Acquaviva delle Fonti
Italy	Ospedali Riuniti di Ancona	Ancona
Italy	Casa di Cura Villa Margherita	Arcugnano
Italy	Spedali Civili Di Brescia Azienda Ospedaliera	Brescia
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Italy	IRCCS San Raffaele Pisana	Roma
Italy	NCL Neurological Centre of Latium	Roma
Italy	Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona	Salerno
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Poland	Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED	Czestochowa
Poland	Centrum Medyczne Pratia Katowice I	Katowice
Poland	NEURO-CARE Site Management Organization Gabriela Klodowska-Duda	Katowice
Poland	Krakowska Akademia Neurologii Sp. z o. o.	Krakow
Poland	Gabinet Lekarski Prof. Andrzej Bogucki	Lodz
Poland	Centrum Medyczne Damiana Holding	Warszawa
Poland	Centrum Medyczne Pratia Warszawa	Warszawa
Slovakia	Konzílium	Dubnica nad Váhom	Trencin
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda
Spain	Hospital Sant Joan de Deu de Manresa	Manresa
Ukraine	Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability	Cherkasy
Ukraine	Dnipropetrovsk medical academy MOH of Ukraine	Dnipropetrovs'k
Ukraine	Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine	Kharkiv
Ukraine	Kharkiv regional clinical psychiatry hospital #3	Kharkiv
Ukraine	Lviv City Clinical Hospital	L'viv
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
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	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent
United States	Asheville Neurology Specialists	Asheville	North Carolina
United States	University of Colorado Dept. of Neurology	Aurora	Colorado
United States	North Texas Movement Disorders Institute	Bedford	Texas
United States	University Alabama Hospital Neurology	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	David L. Kreitzman, MD., PC	Commack	New York
United States	Michigan State University	East Lansing	Michigan
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Parkinson's Disease & Movement Disorders Center	Fountain Valley	California
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine Department of Neurology	Houston	Texas
United States	The University of Kansas Hospital	Kansas City	Kansas
United States	Booth Garner Parkinson's Care Center	Kirkland	Washington
United States	Dartmouth Hitchcock Neurology	Lebanon	New Hampshire
United States	Loma Linda University Medical Center	Loma Linda	California
United States	University of Southern California	Los Angeles	California
United States	Collier Neurologic Specialists, LLC	Naples	Florida
United States	Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences	Nashville	Tennessee
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	Bioclinica Research	Orlando	Florida
United States	SC3 Research	Pasadena	California
United States	Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center	Phoenix	Arizona
United States	SC3 Research	Reseda	California
United States	Atlantic Health System Hospital Corp.-Overlook Hospital	Summit	New Jersey
United States	Banner Sun Health Research Institute	Sun City	Arizona
United States	Parkinson's Disease and Movement Disorders Center	Tampa	Florida
United States	University of Toledo	Toledo	Ohio
United States	The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma
United States	Hartford HealthCare	Vernon	Connecticut
United States	Sentara Neurology Specialists	Virginia Beach	Virginia
United States	Henry Ford Hospital	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Intec Pharma Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  Israel,  Italy,  Poland,  Slovakia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety (Adverse Events, Safety laboratory, Vital signs)	Adverse Events, Safety laboratory, Vital signs	One Year
Secondary	Change in Parkinson's disease Questionnaire - 39 items (PDQ39).	Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).	Base line to end of study ( week 53)