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

Parkinson's Disease Clinical Trial

— BouNDless  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04006210
• Other study ID #: ND0612-317
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 30, 2019
• Est. completion date: February 2027

Study information

• Verified date: November 2023
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 381
• Est. completion date: February 2027
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patients, aged =30 years.

2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria.

3. Modi?ed 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 con?rmed 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 signi?cant skin conditions or disorders.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Combination Product:
• ND0612 Solution for SC infusion
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
• Placebo for SC infusion
Placebo solution administered SC via infusion pump

Drug:
• Oral IR-LD/CD
Encapsulated LD/CD 100mg/25mg
• Placebo for Oral IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
Belgium	CHU de Tivoli	La Louvière
Czechia	Neurologicka klinika Fakutni nemocnice sv. Anny v Brne	Brno
Czechia	Axon Clinical s.r.o.	Praha 5
France	Hopital Neurologique	Bron
France	Hopital Gabriel Montpied	Clermont-Ferrand
France	CHU Nantes-Hopital Laennec	Nantes
France	CHU de Nice Hpital Pasteur	Nice
France	Chu Caremeau	Nimes
France	Hopital Purpan	Toulouse
Hungary	University of Pecs, Clinical Center	Pécs
Israel	Hadassah Medical Center, Ein Kerem	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical center- Nahariya	Nahariya
Israel	Rabin Medical Center, Beilinson Hospital	Petah Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Casa di Cura Villa Margherita	Arcugnano
Italy	Centro Ricerca Parkinson San Raffaele Cassino	Cassino
Italy	University Chieti CeSI MET Clinical research center-CRC	Chieti
Italy	Ospedale di Grosseto, Azienda USL Toscana Sud Est	Grosseto
Italy	Istituto Clinico Humanitas - IRCCS	Milano
Italy	AOU University of Campania "Luigi Vanvitelli"	Naples
Italy	IRCCS Fondazione C. Mondino	Pavia
Italy	IRCCS San Raffaele Pisana	Roma
Italy	IRCCS Santa Lucia Foundation	Rome
Italy	Policlinico Tor Vergata - UOSD Parkinson	Rome
Netherlands	University of Amsterdam	Amsterdam
Poland	Krakowska Akademia Neurologii Sp. z o. o	Krakow
Poland	NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki	Lodz
Poland	Neuro-Care SP z o. o.	Siemianowice Slaskie
Poland	Oddzial Neurologii ul. L. Kondratowicza 8	Warsaw
Portugal	Hospital Braga	Braga
Portugal	CNS - Campus Neurologico Senior	Torres Vedras
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	Federal Siberian Scientic Clinical Center of FMBA	Krasnoyarsk
Russian Federation	Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34	Novosibirsk
Russian Federation	The first Saint-Petersburg State Medical University named after IP Pavlov	St. Petersburg
Russian Federation	Siberian State Medical University	Tomsk
Slovakia	Nemocnica akad. L. Derera	Bratislava
Slovakia	Univerzitna nemocnica L. Pasteura Kosice	Kosice
Spain	Hospital General Universitario de Elche, Edificio principal	Alicante
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitari de la Vall d'Hebron	Barcelona
Spain	Hospital Universitari General de Catalunya	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Complejo Hospitalario Ruber Juan Bravo	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Infanta Sofia	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Virgen del Rocío, Laboratorio 104.	Sevilla
Spain	Hospital Universitario y Politcnico de La Fe	Valencia
Ukraine	Clinic "Dopomoga Plus"	Kyiv
Ukraine	Institute of Gerontolgoy - Parkinsons disease Treatment Centre	Kyiv
Ukraine	Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy	Poltava
Ukraine	Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital	Vinnytsia
Ukraine	Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council	Zaporozhye
United Kingdom	Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust	London
United Kingdom	King's College hospital	London
United Kingdom	St Georges University Hospital	London
United Kingdom	Clinical Ageing research Unit	Newcastle
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth
United States	Emory University - Brain Health Center	Atlanta	Georgia
United States	Visionary Investigators Network	Aventura	Florida
United States	Parkinsons Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Neurology Consultants of Dallas	Dallas	Texas
United States	NeuroStudies	Decatur	Georgia
United States	Unity Point Health	Des Moines	Iowa
United States	Duke University	Durham	North Carolina
United States	Michigan State University	East Lansing	Michigan
United States	Rocky Mountain Movement Disorders Center	Englewood	Colorado
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	University of Florida Norman Fixel Institute for Neurological Diseases	Gainesville	Florida
United States	Hawaii Pacific Neuroscience	Honolulu	Hawaii
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kentucky, Neurology and Movement Disorder	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Cedar- Sinai Medical Center Department of Neurology	Los Angeles	California
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	Neurology Associates PA	Maitland	Florida
United States	Rutgers-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Oschner Medical Center	New Orleans	Louisiana
United States	Mount Sinai Medical center Movement Disorders Center	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Corporal Michael J. Crescenz VA Medical Center	Philadelphia	Pennsylvania
United States	Xenoscience	Phoenix	Arizona
United States	SC3 Research - Reseda	Reseda	California
United States	University of California San Francisco	San Francisco	California
United States	USF Parkinson's Disease and Movement Disorders Center	Tampa	Florida
United States	Hartford Healthcare Chase Family Movement Disorders Center	Vernon	Connecticut
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	Abington Neurological Associates LTD.	Willow Grove	Pennsylvania
United States	Neurology One	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NeuroDerm Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  France,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in daily ON time without troublesome dyskinesia	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	The change in daily OFF time	OFF time per patient diary	Baseline to the end of DBDD Maintenance Period (12 weeks)

External Links

•   European Union Clinical Trials Register