A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients
NCT ID: NCT02605434
Last Updated: 2019-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
420 participants
INTERVENTIONAL
2016-03-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AP-CD/LD
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 and Placebo IR Carbidopa/ levodopa
Accordion Pill™ Carbidopa/Levodopa
AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day
Placebo -AP-CD/LD
Placebo for AP-CD/LD capsule
SINEMET®
IR Carbidopa/ levodopa tablets 25/100 mg at least 4 times a day and placebo AP-CD/LD
Sinemet®
Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
Placebo- Sinemet
Placebo for Sinemet tables
Interventions
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Accordion Pill™ Carbidopa/Levodopa
AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day
Sinemet®
Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
Placebo -AP-CD/LD
Placebo for AP-CD/LD capsule
Placebo- Sinemet
Placebo for Sinemet tables
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able and willing to give written (signed and dated) informed consent and adhere to visit schedule and available to complete the study
3. Men or women 30 years of age and higher at initial screening assessment. (For the 100 subjects who enter the Gastroscopy sub study, the age limits are 30-80 years of age, inclusive, at initial screening assessment)
4. Diagnosed with Parkinson's disease, consistent with UK brain bank criteria
5. Has a good response to Levodopa and is taking at least 4 doses of a Levodopa containing medication (or 3 doses of Rytary) per day during waking hours (not including nighttime long acting levodopa) at a stable dose for at least 28 days prior to initial screening assessment
6. Other Anti-PD treatment (such as dopamine agonists, selective MAO-B inhibitors, anticholinergic agents or Amantadine) are permitted if stable for at least 28 days prior to study entry and provided they are not anticipated to be changed during the course of the study
7. Total LD immediate release daily dose of 400 mg to 1300 mg or equivalent prior to initial screening assessment. Specifically for Rytary, doses up to 1755 mg daily are acceptable.
8. Able to complete a Hauser Home Diary and can tell the difference between "On" and "Off" time
1. Achieved at least 75% diary concordance with an approved site rater in a 4-hour training session including at least one "Off time" assessment
2. Returned a valid 2-day practice diary after training has been completed.
9. At least 2.5 hours "Off time" per day during waking hours on Screening 2-day Practice Hauser Home Diary (morning akinesia should be incorporated into the total "Off time" assessment).
10. Other than PD, the subject is in satisfactory health, as assessed by physical examination and screening tests. No clinically significant medical, psychiatric or laboratory abnormality that could compromise safety or interfere with study procedures in the opinion of either the investigator or the Enrollment Approval Committee/Sponsor.
11. Living in an area that is within 3 hours driving distance from the study site or is willing to stay in such a place the night before each study visit
Exclusion Criteria
2. Atypical Parkinsonism (subjects with Parkinsonian features caused by disorder such as multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies or multiple brain infarcts)
3. Clinically significant cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which contraindicates his/her participation in the opinion of either the investigator or the Enrollment Approval Committee/Sponsor.
4. Severe dyskinesia in the opinion of either the investigator or the Enrollment Approval Committee.
5. Treatment with non-selective monoamine oxidase (MAO) inhibitors during the last 28 days prior to initial screening assessment or planning to take during study participation
6. Previous or planned neurosurgical treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation) during the course of the study
7. Significant cognitive impairment as defined by the Mini-Mental State Examination (MMSE) score \< 26.
8. Clinically significant psychiatric illness, including major depression (Hamilton Depression Rating Scale-17 ≥14). Subjects with a lifetime history of suicidal attempt (including an active attempt, interrupted attempt or aborted attempt)
9. Current or previous treatment for more than 1 month within the past 2 years with any neuroleptic drug (antipsychotic) or any other drug with anti-dopaminergic properties (e.g. metoclopramide, domperidone)
10. Currently experiencing or any known history of psychosis or delusions within 2 years prior to Screening.
11. Known history of substance abuse within the past 2 years
12. Moderate or greater level of alcohol consumption
13. Unable to swallow large pills (e.g., large vitamin pills)
14. History of Melanoma or suspicious skin lesion which could be a Melanoma
15. Narrow-angle Glaucoma
16. History of small bowel or gastric surgery (Including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, or frequent nausea or emesis, regardless of etiology, (Previous appendectomy or hernioplasty will not be exclusionary).
17. Active peptic ulcer disease or a history of peptic ulcer or upper GI bleeding
18. Regular use of opioids (Intermittent opioid use is not exclusionary)
19. Symptomatic gastroparesis with frequent vomiting (at least once a week)
20. Concomitant use of NSAIDs and oral steroids within the past 28 days
21. Allergy to the study drug or any of its excipients, or to Yellow Dye #5 (tartrazine)
22. Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.
30 Years
ALL
No
Sponsors
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Intec Pharma Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter A LeWitt, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital - West Bloomfield
Locations
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University Alabama Hospital Neurology
Birmingham, Alabama, United States
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, United States
Parkinson's Disease & Movement Disorders Center, Dept of Neu
Fountain Valley, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
University of Southern California
Los Angeles, California, United States
SC3 Research
Pasadena, California, United States
SC3 Research
Reseda, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of Colorado Dept. of Neurology
Aurora, Colorado, United States
Hartford HealthCare
Vernon, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Collier Neurologic Specialists, LLC
Naples, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Henry Ford Hospital
West Bloomfield, Michigan, United States
Dartmouth Hitchcock Neurology
Lebanon, New Hampshire, United States
Atlantic Health System Hospital Corp.-Overlook Hospital
Summit, New Jersey, United States
David L. Kreitzman, MD., PC
Commack, New York, United States
Fresco Institute 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
Asheville Neurology Specialists
Asheville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Toledo
Toledo, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences
Nashville, Tennessee, United States
North Texas Movement Disorders Institute
Bedford, Texas, United States
Baylor College of Medicine Department of Neurology
Houston, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Booth Garner Parkinson's Care Center
Kirkland, Washington, United States
MHAT 'Sv.Pantaleymon - Pleven' OOD
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, , Bulgaria
Clinic for Neurology and Sleep Medicine
Sofia, , Bulgaria
Clinic of Neurological Diseases
Sofia, , Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD
Varna, , Bulgaria
Neuroakademie Alzenau GbR
Aschaffenburg, , Germany
Praxis für Neurologie und Psychiatrie
Berlin, , Germany
Uniklinikum Carl-Gustav Carus an der TU Dresden
Dresden, , Germany
Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar
München, , Germany
Praxis für Neurologie und Psychiatrie
Westerstede, , Germany
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Chaim Sheba Medical Center at Tel Hashomer
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedale Generale Regionale Francesco Miulli
Acquaviva delle Fonti, , Italy
Ospedali Riuniti di Ancona
Ancona, , Italy
Spedali Civili Di Brescia Azienda Ospedaliera
Brescia, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
IRCCS Neurologico Fondazione "C. Mondino"
Pavia, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
IRCCS San Raffaele Pisana
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
Salerno, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Azienda Unitá Locale Socio Sanitaria 12 Veneziana - Ospedale dell'Angelo
Venezia, , Italy
Casa di Cura Villa Margherita
Vicenza, , Italy
Centrum Medyczne Damiana Holding
Warsaw, Masovian Voivodeship, Poland
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz, , Poland
Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
Częstochowa, , Poland
NEURO-CARE Site Management Organization Gabriela Klodowska-Duda
Katowice, , Poland
Centrum Medyczne Pratia Katowice I
Katowice, , Poland
Krakowska Akademia Neurologii Sp. z o. o.
Krakow, , Poland
Gabinet Lekarski Prof. Andrzej Bogucki
Lodz, , Poland
Centrum Medyczne Pratia Warszawa
Warsaw, , Poland
Neurologicka ambulancia, Euro-Neuro s.r.o.
Bratislava, , Slovakia
KONZÍLIUM s.r.o.
Považská Bystrica, , Slovakia
NEURON - D.T. s.r.o.
Žilina, , Slovakia
HM Puerta del Sur
Móstoles, Madrid, Spain
Hospital Universitari Quirón Dexeus
Barcelona, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, , Spain
Hospital General de Cataluña
Sant Cugat del Vallès, , Spain
Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability
Cherkasy, , Ukraine
Dnipropetrovsk medical academy MOH of Ukraine
Dnipro, , Ukraine
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, , Ukraine
State Institution "Institute of Gerontology of the AMS of Ukraine"
Kyiv, , Ukraine
Lviv City Clinical Hospital
Lviv, , Ukraine
Regional Clinical Hospital n.a. N.V. Sklifosovskyi
Poltava, , Ukraine
Municipal Institution "Zaporizhzhya City Clinical Multidisciplinary Hospital #9"
Zaporizhzhya, , Ukraine
Municipal Institution 6¿ City Clinical Hospital
Zaporizhzhya, , Ukraine
Clinical Hospital #2
Zaporozh’ye, , Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporozh’ye, , Ukraine
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 Kingdom
Countries
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References
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McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS: 1. GENE THERAPY FOR PARKINSON'S, 2. PHASE 3 STUDY IN FOCUS - INTEC PHARMA'S ACCORDION PILL, 3. CLINICAL TRIALS RESOURCES. J Parkinsons Dis. 2019;9(2):251-264. doi: 10.3233/JPD-199001. No abstract available.
Other Identifiers
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IN 11 004
Identifier Type: -
Identifier Source: org_study_id
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