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Trial record 3 of 5 for:    intec parkinson's

A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients (Accordance)

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ClinicalTrials.gov Identifier: NCT02605434
Recruitment Status : Unknown
Verified April 2018 by Intec Pharma Ltd..
Recruitment status was:  Active, not recruiting
First Posted : November 16, 2015
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Intec Pharma Ltd.

Brief Summary:
The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Accordion Pill™ Carbidopa/Levodopa Drug: Sinemet® Drug: Placebo -AP-CD/LD Drug: Placebo- Sinemet Phase 3

Detailed Description:
A multi-center, global, randomized, double-blind, double-dummy, active-controlled, parallel-group study in adult subjects with fluctuating PD. The study will have 2 open label Titration periods of 6 weeks each prior to the double blind Maintenance period. In the open label periods all patients will be stabilized on the active comparator Sinemet® and then on AP-CD/LD. The double blind Maintenance period will be 13 weeks long.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients
Study Start Date : March 2016
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: 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
Other Name: AP-CD/LD

Drug: Placebo -AP-CD/LD
Placebo for AP-CD/LD capsule

Active Comparator: SINEMET®
IR Carbidopa/ levodopa tablets 25/100 mg at least 4 times a day and placebo AP-CD/LD
Drug: Sinemet®
Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
Other Name: IR Carbidopa/Levodopa

Drug: Placebo- Sinemet
Placebo for Sinemet tables




Primary Outcome Measures :
  1. Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours [ Time Frame: Baseline through study completion, an average of 27 weeks ]
    Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours based on Hauser Home Diary assessments; Total number of "Off " hours normalized to a 16- hour waking day will also be calculated but only a single p-value applicable to both the percentage and hours will be reported.


Secondary Outcome Measures :
  1. Change from Baseline through study completion, an average of 27 weeks, in "On time" without troublesome dyskinesia during waking hours [ Time Frame: Baseline through study completion, an average of 27 weeks ]
  2. Change in the number of total daily LD doses from Baseline through study completion, an average of 27 weeks (hours) [ Time Frame: Baseline through study completion, an average of 27 weeks ]
  3. CGI-I through study completion, an average of 27 weeks, as recorded by physician & patient [ Time Frame: Baseline through through study completion, an average of 27 weeks, ]
  4. Change from Baseline through study completion, an average of 27 weeks, in total UPDRS Score (Sum of Parts I-III) [ Time Frame: Baseline through study completion, an average of 27 weeks ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Subjects must be approved for suitability by an Enrollment Approval Committee
  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

Main Exclusion Criteria:

  1. Participation in another drug clinical trial within 28 days prior to initial screening assessment (calculated from the previous study's last dosing date)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605434


Locations
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United States, Alabama
University Alabama Hospital Neurology
Birmingham, Alabama, United States, 35233
United States, Arizona
Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center
Phoenix, Arizona, United States, 85013
United States, California
Parkinson's Disease & Movement Disorders Center, Dept of Neu
Fountain Valley, California, United States, 92708
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
University of Southern California
Los Angeles, California, United States, 90033
SC3 Research
Pasadena, California, United States, 91105
SC3 Research
Reseda, California, United States, 91335
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Dept. of Neurology
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford HealthCare
Vernon, Connecticut, United States, 06066
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Collier Neurologic Specialists, LLC
Naples, Florida, United States, 34102
Bioclinica Research
Orlando, Florida, United States, 32806
Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Kansas
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Henry Ford Hospital
West Bloomfield, Michigan, United States, 48322
United States, New Hampshire
Dartmouth Hitchcock Neurology
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Atlantic Health System Hospital Corp.-Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
David L. Kreitzman, MD., PC
Commack, New York, United States, 11725
Fresco Institute for Parkinson's and Movement Disorders
New York, New York, United States, 10016
Weill Cornell Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Asheville Neurology Specialists
Asheville, North Carolina, United States, 28806
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0525
University of Toledo
Toledo, Ohio, United States, 43614
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Tennessee
Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences
Nashville, Tennessee, United States, 37232
United States, Texas
North Texas Movement Disorders Institute
Bedford, Texas, United States, 76021
Baylor College of Medicine Department of Neurology
Houston, Texas, United States, 77030
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
United States, Washington
Booth Garner Parkinson's Care Center
Kirkland, Washington, United States, 98034
Bulgaria
MHAT 'Sv.Pantaleymon - Pleven' OOD
Pleven, Bulgaria, 5800
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, Bulgaria, 4002
Clinic for Neurology and Sleep Medicine
Sofia, Bulgaria, 1407
Clinic of Neurological Diseases
Sofia, Bulgaria, 1797
Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD
Varna, Bulgaria, 9010
Germany
Neuroakademie Alzenau GbR
Aschaffenburg, Germany, 63755
Praxis für Neurologie und Psychiatrie
Berlin, Germany, 12163
Uniklinikum Carl-Gustav Carus an der TU Dresden
Dresden, Germany, 01307
Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar
Munchen, Germany, 81675
Praxis für Neurologie und Psychiatrie
Westerstede, Germany, 26655
Israel
Rambam Medical Center
Haifa, Israel
Rabin Medical Center
Petah Tiqva, Israel, 4941492
Chaim Sheba Medical Center at Tel Hashomer
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
Ospedale Generale Regionale Francesco Miulli
Acquaviva delle Fonti, Italy, 70021
Ospedali Riuniti di Ancona
Ancona, Italy, 60126
Spedali Civili Di Brescia Azienda Ospedaliera
Brescia, Italy, 25123
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy, 80131
IRCCS Neurologico Fondazione "C. Mondino"
Pavia, Italy, 27100
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126
IRCCS San Raffaele Pisana
Roma, Italy, 00163
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona
Salerno, Italy, 84131
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Azienda Unitá Locale Socio Sanitaria 12 Veneziana - Ospedale dell'Angelo
Venezia, Italy, 30174
Casa di Cura Villa Margherita
Vicenza, Italy, 36057
Poland
Centrum Medyczne Damiana Holding
Warszawa, Mazowieckie, Poland, 02-777
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz, Poland, 85-021
Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED
Czestochowa, Poland, 42-280
NEURO-CARE Site Management Organization Gabriela Klodowska-Duda
Katowice, Poland, 40-749
Centrum Medyczne Pratia Katowice I
Katowice, Poland, 40-954
Krakowska Akademia Neurologii Sp. z o. o.
Krakow, Poland, 31-505
Gabinet Lekarski Prof. Andrzej Bogucki
Lodz, Poland, 90-130
Centrum Medyczne Pratia Warszawa
Warszawa, Poland, 01-868
Slovakia
Neurologicka ambulancia, Euro-Neuro s.r.o.
Bratislava, Slovakia, 83103
KONZÍLIUM s.r.o.
Považská Bystrica, Slovakia, 01726
NEURON - D.T. s.r.o.
Zilina, Slovakia, 01001
Spain
HM Puerta del Sur
Mostoles, Madrid, Spain, 28938
Hospital Universitari Quirón Dexeus
Barcelona, Spain, 08028
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Ruber Internacional
Madrid, Spain, 28034
Hospital Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Hospital Infanta Sofía
San Sebastian de los Reyes, Spain, 28702
Hospital General de Cataluña
Sant Cugat del Valles, Spain, 08195
Ukraine
Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability
Cherkasy, Ukraine, 18009
Dnipropetrovsk medical academy MOH of Ukraine
Dnipropetrovs'k, Ukraine
Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, Ukraine, 61068
State Institution "Institute of Gerontology of the AMS of Ukraine"
Kyiv, Ukraine, 04114
Lviv City Clinical Hospital
L'viv, Ukraine, 79010
Regional Clinical Hospital n.a. N.V. Sklifosovskyi
Poltava, Ukraine, 36024
Municipal Institution "Zaporizhzhya City Clinical Multidisciplinary Hospital #9"
Zaporizhzhya, Ukraine, 69035
Municipal Institution 6¿ City Clinical Hospital
Zaporizhzhya, Ukraine, 69035
Clinical Hospital #2
Zaporozh'ye, Ukraine, 69600
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporozh'ye, Ukraine, 69600
United Kingdom
Fairfield General Hospital
Bury, United Kingdom, BL9 7TD
Newcastle University Clinical Ageing Research
Newcastle upon Tyne, United Kingdom, NE4 5PL
Queens Medical Centre Nottingham, University Hospital
Nottingham, United Kingdom, NG7 2UH
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Intec Pharma Ltd.
Investigators
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Principal Investigator: Peter A LeWitt, MD Henry Ford Hospital - West Bloomfield
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02605434    
Other Study ID Numbers: IN 11 004
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: April 2018
Keywords provided by Intec Pharma Ltd.:
Parkinson's Disease
Fluctuating Parkinson's Disease
Advanced Parkinson's Disease
Carbidopa
Levodopa
Accordion
Accordance
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists