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Parkinson's DiseasePhase 3AccordanceNCT02605434

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

A Phase 3 study testing Accordion Pill™ Carbidopa/Levodopa and Sinemet® in people with Parkinson's Disease, run by Intec Pharma Ltd. at 97 sites in 10 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
Accordion Pill™ Carbidopa/Levodopa and Sinemet®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
97 sitesin 10 countries
Study dates
Mar 2016to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  9. Achieved at least 75% diary concordance with an approved site rater in a 4-hour training session including at least one "Off time" assessment
  10. Returned a valid 2-day practice diary after training has been completed.
  11. 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).
  12. 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.
  13. 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.

Trial locations and contacts

97 sites in 10 countries.

97 sites in 10 countries

United States36 sites

  • Asheville Neurology Specialists

    Asheville, North Carolina, 28806

  • University of Colorado Dept. of Neurology

    Aurora, Colorado, 80045

  • North Texas Movement Disorders Institute

    Bedford, Texas, 76021

  • University Alabama Hospital Neurology

    Birmingham, Alabama, 35233

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0525

  • David L. Kreitzman, MD., PC

    Commack, New York, 11725

  • Michigan State University

    East Lansing, Michigan, 48824

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Parkinson's Disease & Movement Disorders Center, Dept of Neu

    Fountain Valley, California, 92708

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine Department of Neurology

    Houston, Texas, 77030

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Booth Garner Parkinson's Care Center

    Kirkland, Washington, 98034

  • Dartmouth Hitchcock Neurology

    Lebanon, New Hampshire, 03756

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • University of Southern California

    Los Angeles, California, 90033

  • Collier Neurologic Specialists, LLC

    Naples, Florida, 34102

  • Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences

    Nashville, Tennessee, 37232

  • Fresco Institute for Parkinson's and Movement Disorders

    New York, New York, 10016

  • Weill Cornell Medical College of Cornell University

    New York, New York, 10021

  • Bioclinica Research

    Orlando, Florida, 32806

  • SC3 Research

    Pasadena, California, 91105

  • Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center

    Phoenix, Arizona, 85013

  • SC3 Research

    Reseda, California, 91335

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Atlantic Health System Hospital Corp.-Overlook Hospital

    Summit, New Jersey, 07902

  • Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

  • University of Toledo

    Toledo, Ohio, 43614

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • Hartford HealthCare

    Vernon, Connecticut, 06066

  • Henry Ford Hospital

    West Bloomfield, Michigan, 48322

Other trials in United States

Italy12 sites

  • Ospedale Generale Regionale Francesco Miulli

    Acquaviva delle Fonti, 70021

  • Ospedali Riuniti di Ancona

    Ancona, 60126

  • Spedali Civili Di Brescia Azienda Ospedaliera

    Brescia, 25123

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • IRCCS Neurologico Fondazione "C. Mondino"

    Pavia, 27100

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • IRCCS San Raffaele Pisana

    Roma, 00163

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Azienda Ospedaliera Universitaria San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84131

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

  • Azienda Unitá Locale Socio Sanitaria 12 Veneziana - Ospedale dell'Angelo

    Venezia, 30174

  • Casa di Cura Villa Margherita

    Vicenza, 36057

Other trials in Italy

Spain10 sites

  • Hospital Universitari Quirón Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • HM Puerta del Sur

    Móstoles, Madrid, 28938

  • Hospital Infanta Sofía

    San Sebastián de los Reyes, 28702

  • Hospital General de Cataluña

    Sant Cugat del Vallès, 08195

Other trials in Spain

Ukraine10 sites

  • Ukrainian State Scientific Research Institution of Medical and Social Problems of Disability

    Cherkasy, 18009

  • Dnipropetrovsk medical academy MOH of Ukraine

    Dnipro

  • Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine

    Kharkiv, 61068

  • State Institution "Institute of Gerontology of the AMS of Ukraine"

    Kyiv, 04114

  • Lviv City Clinical Hospital

    Lviv, 79010

  • Regional Clinical Hospital n.a. N.V. Sklifosovskyi

    Poltava, 36024

  • Municipal Institution "Zaporizhzhya City Clinical Multidisciplinary Hospital #9"

    Zaporizhzhya, 69035

  • Municipal Institution 6¿ City Clinical Hospital

    Zaporizhzhya, 69035

  • Clinical Hospital #2

    Zaporozh’ye, 69600

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporozh’ye, 69600

Other trials in Ukraine

Poland8 sites

  • VITAMED Galaj i Cichomski spólka jawna

    Bydgoszcz, 85-021

  • Anna Kapustecka Prywatna Przychodnia Specjalistyczna STOMED

    Częstochowa, 42-280

  • NEURO-CARE Site Management Organization Gabriela Klodowska-Duda

    Katowice, 40-749

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-954

  • Krakowska Akademia Neurologii Sp. z o. o.

    Krakow, 31-505

  • Gabinet Lekarski Prof. Andrzej Bogucki

    Lodz, 90-130

  • Centrum Medyczne Damiana Holding

    Warsaw, Masovian Voivodeship, 02-777

  • Centrum Medyczne Pratia Warszawa

    Warsaw, 01-868

Other trials in Poland

Bulgaria5 sites

  • MHAT 'Sv.Pantaleymon - Pleven' OOD

    Pleven, 5800

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

    Plovdiv, 4002

  • Clinic for Neurology and Sleep Medicine

    Sofia, 1407

  • Clinic of Neurological Diseases

    Sofia, 1797

  • Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD

    Varna, 9010

Other trials in Bulgaria

Germany5 sites

  • Neuroakademie Alzenau GbR

    Aschaffenburg, 63755

  • Praxis für Neurologie und Psychiatrie

    Berlin, 12163

  • Uniklinikum Carl-Gustav Carus an der TU Dresden

    Dresden, 01307

  • Technischen Universitaet Muenchen (TUM) - Klinikum Rechts der Isar

    München, 81675

  • Praxis für Neurologie und Psychiatrie

    Westerstede, 26655

Other trials in Germany

Israel4 sites

  • Rambam Medical Center

    Haifa

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center at Tel Hashomer

    Ramat Gan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

United Kingdom4 sites

  • Fairfield General Hospital

    Bury, BL9 7TD

  • Newcastle University Clinical Ageing Research

    Newcastle upon Tyne, NE4 5PL

  • Queens Medical Centre Nottingham, University Hospital

    Nottingham, NG7 2UH

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Slovakia3 sites

  • Neurologicka ambulancia, Euro-Neuro s.r.o.

    Bratislava, 83103

  • KONZÍLIUM s.r.o.

    Považská Bystrica, 01726

  • NEURON - D.T. s.r.o.

    Žilina, 01001

Other trials in Slovakia

About this study

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

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.

Read the 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.

Being tested
Accordion Pill™ Carbidopa/Levodopa, Sinemet®, Placebo -AP-CD/LD, Placebo- Sinemet
Keywords
Parkinson's Disease, Fluctuating Parkinson's Disease, Advanced Parkinson's Disease, Carbidopa, Levodopa, Accordion, Accordance
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accordion Pill™ Carbidopa/LevodopaDrug

    Also called AP-CD/LD

    AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day

  • Sinemet®Drug

    Also called IR Carbidopa/Levodopa

    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/LDDrug

    Placebo for AP-CD/LD capsule

  • Placebo- SinemetDrug

    Placebo for Sinemet tables

Study groups in NCT02605434
Study groupRoleWhat they receive
AP-CD/LDExperimentalAccordion 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
Receives: Drug: Accordion Pill™ Carbidopa/Levodopa; Drug: Placebo -AP-CD/LD
SINEMET®Active comparatorIR Carbidopa/ levodopa tablets 25/100 mg at least 4 times a day and placebo AP-CD/LD
Receives: Drug: Sinemet®; Drug: Placebo- Sinemet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours

    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.

    Measured: Baseline through study completion, an average of 27 weeks

Secondary outcomes (4)

  1. Change from Baseline through study completion, an average of 27 weeks, in "On time" without troublesome dyskinesia during waking hours

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: Baseline through study completion, an average of 27 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2015 (estimated)
  2. Study startMar 2016
  3. Primary completionJul 2019
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605434
Sponsor's protocol ID
IN 11 004
Acronym
Accordance
Status last verified
Apr 2018
First submitted
5 Nov 2015
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31127735

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Accordion Pill™ Carbidopa/Levodopa and Sinemet® in people with Parkinson's Disease, run by Intec Pharma Ltd. at 97 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Italy, Spain, Ukraine, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02605434, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.

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