Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

November 5, 2023 updated by: NeuroDerm Ltd.

A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel-group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD.

Subjects can continue to an optional open-label extension period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy (DBDD), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (SC) ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease (PD) experiencing motor fluctuations.

This study is comprised of 6 periods:

  1. a Screening Period;
  2. an open-label oral IR-LD/CD Adjustment Period;
  3. an open-label ND0612 Conversion Period;
  4. a randomized DBDD active-controlled Maintenance Period;
  5. an optional open-label Treatment Extension; and
  6. a Safety Follow-up Period.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University Innsbruck
  • Belgium
      • La Louvière, Belgium, 7100
        • CHU de Tivoli
  • Czechia
      • Brno, Czechia, 65691
        • Neurologicka klinika Fakutni nemocnice sv. Anny v Brne
      • Praha 5, Czechia, 150 00
        • AXON Clinical s.r.o.
  • France
      • Bron, France, 69677
        • Hôpital Neurologique
      • Clermont-Ferrand, France, 63000
        • Hôpital Gabriel Montpied
      • Nantes, France, 44800
        • CHU Nantes-Hopital Laennec
      • Nice, France, 6002
        • CHU de Nice Hpital Pasteur
      • Nimes, France, GARD 30000
        • CHU Caremeau
      • Toulouse, France, 31059
        • Hopital Purpan
  • Hungary
      • Pécs, Hungary, 7623
        • University of Pecs, Clinical Center
  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center, Ein Kerem
      • Nahariya, Israel, 22100
        • Galilee Medical center- Nahariya
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center, Beilinson Hospital
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Arcugnano, Italy, 36057
        • Casa di Cura Villa Margherita
      • Cassino, Italy, 03043
        • Centro Ricerca Parkinson San Raffaele Cassino
      • Chieti, Italy, 66100
        • University Chieti CeSI MET Clinical research center-CRC
      • Grosseto, Italy, 58100
        • Ospedale di Grosseto, Azienda USL Toscana Sud Est
      • Milano, Italy, 20089
        • Istituto Clinico Humanitas - IRCCS
      • Naples, Italy, 80138
        • AOU University of Campania "Luigi Vanvitelli"
      • Pavia, Italy, 27100
        • IRCCS Fondazione C. Mondino
      • Roma, Italy, RM 163
        • IRCCS San Raffaele Pisana
      • Rome, Italy, 00133
        • Policlinico Tor Vergata - UOSD Parkinson
      • Rome, Italy, 179
        • IRCCS Santa Lucia Foundation
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • University of Amsterdam
  • Poland
      • Krakow, Poland, 31-505
        • Krakowska Akademia Neurologii Sp. z o. o
      • Lodz, Poland, 90-640
        • NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
      • Siemianowice Śląskie, Poland, 41-100
        • Neuro-Care SP z o. o.
      • Warsaw, Poland, 03-242
        • Oddział Neurologii ul. L. Kondratowicza 8
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital Braga
      • Torres Vedras, Portugal, 256-280
        • CNS - Campus Neurologico Senior
  • Russian Federation
      • Kazan, Russian Federation, 420012
        • Kazan State Medical University
      • Krasnoyarsk, Russian Federation, 660037
        • Federal Siberian Scientic Clinical Center of FMBA
      • Novosibirsk, Russian Federation, 630054
        • Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
      • St. Petersburg, Russian Federation, 197022
        • The first Saint-Petersburg State Medical University named after IP Pavlov
      • Tomsk, Russian Federation, 634050
        • Siberian State Medical University
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • Nemocnica akad. L. Derera
      • Kosice, Slovakia, 04166
        • Univerzitna nemocnica L. Pasteura Kosice
  • Spain
      • Alicante, Spain, 03203
        • Hospital General Universitario de Elche, Edificio principal
      • Barcelona, Spain, 08041
        • Hospital de La Santa Creu I Sant Pau
      • Barcelona, Spain, 08035
        • Hospital Universitari de la Vall d'Hebron
      • Barcelona, Spain, 08195
        • Hospital Universitari General de Catalunya
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Madrid, Spain, 28006
        • Complejo Hospitalario Ruber Juan Bravo
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital Universitario Gregorio Marañón
      • Madrid, Spain, 28702
        • Hospital Universitario Infanta Sofía
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío, Laboratorio 104.
      • Valencia, Spain, 46026
        • Hospital Universitario Y Politcnico de La Fe
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
  • Ukraine
      • Kyiv, Ukraine, 04111
        • Clinic "Dopomoga Plus"
      • Kyiv, Ukraine, 4114
        • Institute of Gerontolgoy - Parkinsons disease Treatment Centre
      • Poltava, Ukraine, 36011
        • Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
      • Zaporozhye, Ukraine, 69065
        • Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council
  • United Kingdom
      • London, United Kingdom, SE5 9RT
        • King's College Hospital
      • London, United Kingdom, SW17 0QT
        • St Georges University Hospital
      • London, United Kingdom, W6 8RF
        • Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
      • Newcastle, United Kingdom, NE4 5PL
        • Clinical Ageing research Unit
      • Plymouth, United Kingdom, PL6 5FP
        • University Hospitals Plymouth NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Xenoscience
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Los Angeles, California, United States, 90048 -1804
        • Cedar- Sinai Medical Center Department of Neurology
      • Reseda, California, United States, 91335
        • SC3 Research - Reseda
      • San Francisco, California, United States, 94115
        • University of California San Francisco
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Movement Disorders Center
    • Connecticut
      • Vernon, Connecticut, United States, 06066
        • Hartford Healthcare Chase Family Movement Disorders Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network
      • Boca Raton, Florida, United States, 33486-2359
        • Parkinsons Disease And Movement Disorders Center Of Boca Raton
      • Gainesville, Florida, United States, 32608
        • University of Florida Norman Fixel Institute for Neurological Diseases
      • Maitland, Florida, United States, 32751-4723
        • Neurology Associates PA
      • Tampa, Florida, United States, 33613
        • USF Parkinson's Disease and Movement Disorders Center
      • Winter Park, Florida, United States, 32792
        • Neurology One
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University - Brain Health Center
      • Decatur, Georgia, United States, 30033
        • NeuroStudies
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Unity Point Health
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • University of Kentucky, Neurology and Movement Disorder
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
      • Farmington Hills, Michigan, United States, 48334-2980
        • QUEST Research Institute
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford West Bloomfield Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers-Robert Wood Johnson Medical School
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
      • New York, New York, United States, 10029
        • Mount Sinai Medical center Movement Disorders Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19101-4511
        • Corporal Michael J. Crescenz VA Medical Center
      • Willow Grove, Pennsylvania, United States, 19090-1749
        • Abington Neurological Associates LTD.
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75243
        • Neurology Consultants of Dallas
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908-0816
        • University of Virginia
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2281
        • University of Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female patients, aged ≥30 years.
  2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
  3. Modified Hoehn & Yahr score ≤3 during "ON" state.
  4. Average of ≥2.5 hours of OFF time (≥2 hours "OFF" time every day) during waking hours as confirmed by patient diary over 3 days.
  5. Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of ≥400mg.

Exclusion Criteria:

  1. Atypical or secondary parkinsonism.
  2. Severe disabling dyskinesias, based on Investigator's discretion.
  3. Previous neurosurgery for PD.
  4. Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
  5. Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
  6. Previous participation in ND0612 studies.
  7. History of significant skin conditions or disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ND0612 Group
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Combination product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Names:
  • IR-LD/CD
Drug: Placebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Other Names:
  • Placebo for IR-LD/CD
Active Comparator: IR-LD/CD Group
Placebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks.
Combination product: Placebo for SC infusion
Placebo solution administered SC via infusion pump
Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Names:
  • IR-LD/CD
Drug: Placebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
Other Names:
  • Placebo for IR-LD/CD
Other: Oral IR-LD/CD Adjustment
Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks.
Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Names:
  • IR-LD/CD
Other: ND0612 Conversion
ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks.
Combination product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Drug: Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Other Names:
  • IR-LD/CD
Other: Open-Label Extension
ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months.
Combination product: ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in daily ON time without troublesome dyskinesia
Time Frame: Baseline to the end of DBDD Maintenance Period (12 weeks)
ON time without troublesome dyskinesia is the sum of ON time without dyskinesia and ON time with non-troublesome dyskinesia per patient diary
Baseline to the end of DBDD Maintenance Period (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in daily OFF time
Time Frame: Baseline to the end of DBDD Maintenance Period (12 weeks)
OFF time per patient diary
Baseline to the end of DBDD Maintenance Period (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeuroDerm Ltd.

Investigators

  • Principal Investigator: Alberto J Espay, MD, MSc, University of Cincinnati OH, USA
  • Principal Investigator: Olivier Rascol, MD, PhD, Toulouse University Hospital, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

November 1, 2022

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 30, 2019

First Submitted That Met QC Criteria

June 30, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND0612-317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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