Parkinson's DiseasePhase 3BouNDlessNCT04006210
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
A Phase 3 study testing ND0612 Solution for SC infusion and Oral IR-LD/CD in people with Parkinson's Disease, run by NeuroDerm Ltd. at 103 sites in 16 countries.
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… 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?
- ND0612 Solution for SC infusion and Oral IR-LD/CD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 103 sitesin 16 countries
- Study dates
- 30 Sep 2019to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male and female patients, aged ≥30 years.
- PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
- Modified Hoehn \& Yahr score ≤3 during "ON" state.
- 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.
- 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.
Who cannot join
- Atypical or secondary parkinsonism.
- Severe disabling dyskinesias, based on Investigator's discretion.
- Previous neurosurgery for PD.
- Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
- Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
- Previous participation in ND0612 studies.
- History of significant skin conditions or disorders.
Trial locations and contacts
103 sites in 16 countries.
103 sites in 16 countries
United States38 sites
Emory University - Brain Health Center
Atlanta, Georgia, 30329
Visionary Investigators Network
Aventura, Florida, 33180
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486-2359
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Vermont Medical Center
Burlington, Vermont, 05401
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908-0816
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Neurology Consultants of Dallas
Dallas, Texas, 75243
NeuroStudies
Decatur, Georgia, 30033
Unity Point Health
Des Moines, Iowa, 50309
Duke University
Durham, North Carolina, 27705
Michigan State University
East Lansing, Michigan, 48824
Rocky Mountain Movement Disorders Center
Englewood, Colorado, 80113
QUEST Research Institute
Farmington Hills, Michigan, 48334-2980
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky, Neurology and Movement Disorder
Lexington, Kentucky, 40536-0284
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Cedar- Sinai Medical Center Department of Neurology
Los Angeles, California, 90048 -1804
University of Wisconsin Madison
Madison, Wisconsin, 53705-2281
Neurology Associates PA
Maitland, Florida, 32751-4723
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Oschner Medical Center
New Orleans, Louisiana, 70121
Weill Cornell Medicine
New York, New York, 10021
Mount Sinai Medical center Movement Disorders Center
New York, New York, 10029
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19101-4511
Xenoscience
Phoenix, Arizona, 85004
SC3 Research - Reseda
Reseda, California, 91335
University of California San Francisco
San Francisco, California, 94115
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, 33613
Hartford Healthcare Chase Family Movement Disorders Center
Vernon, Connecticut, 06066
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Abington Neurological Associates LTD.
Willow Grove, Pennsylvania, 19090-1749
Neurology One
Winter Park, Florida, 32792
Spain14 sites
Hospital General Universitario de Elche, Edificio principal
Alicante, 03203
Hospital Universitari de la Vall d'Hebron
Barcelona, 08035
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
Hospital Universitari General de Catalunya
Barcelona, 08195
Hospital Universitario de Burgos
Burgos, 09006
Complejo Hospitalario Ruber Juan Bravo
Madrid, 28006
Hospital Universitario La Princesa
Madrid, 28006
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Infanta Sofia
Madrid, 28702
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Universitario Virgen del Rocío, Laboratorio 104.
Seville, 41013
Hospital Universitario y Politcnico de La Fe
Valencia, 46026
Italy10 sites
Casa di Cura Villa Margherita
Arcugnano, 36057
Centro Ricerca Parkinson San Raffaele Cassino
Cassino, 03043
University Chieti CeSI MET Clinical research center-CRC
Chieti, 66100
Ospedale di Grosseto, Azienda USL Toscana Sud Est
Grosseto, 58100
Istituto Clinico Humanitas - IRCCS
Milan, 20089
AOU University of Campania "Luigi Vanvitelli"
Naples, 80138
IRCCS Fondazione C. Mondino
Pavia, 27100
IRCCS San Raffaele Pisana
Roma, RM 163
Policlinico Tor Vergata - UOSD Parkinson
Rome, 00133
IRCCS Santa Lucia Foundation
Rome, 179
France6 sites
Hopital Neurologique
Bron, 69677
Hopital Gabriel Montpied
Clermont-Ferrand, 63000
CHU Nantes-Hopital Laennec
Nantes, 44800
CHU de Nice Hpital Pasteur
Nice, 6002
Chu Caremeau
Nîmes, GARD 30000
Hopital Purpan
Toulouse, 31059
Israel6 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Medical Center, Ein Kerem
Jerusalem, 9112001
Galilee Medical center- Nahariya
Nahariya, 22100
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100
Chaim Sheba Medical Center
Ramat Gan, 5265601
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Russia5 sites
Kazan State Medical University
Kazan', 420012
Federal Siberian Scientic Clinical Center of FMBA
Krasnoyarsk, 660037
Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34
Novosibirsk, 630054
The first Saint-Petersburg State Medical University named after IP Pavlov
Saint Petersburg, 197022
Siberian State Medical University
Tomsk, 634050
Ukraine5 sites
Clinic "Dopomoga Plus"
Kyiv, 04111
Institute of Gerontolgoy - Parkinsons disease Treatment Centre
Kyiv, 4114
Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy
Poltava, 36011
Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital
Vinnytsia, 21005
Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council
Zaporizhzhya, 69065
United Kingdom5 sites
King's College hospital
London, SE5 9RT
St Georges University Hospital
London, SW17 0QT
Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust
London, W6 8RF
Clinical Ageing research Unit
Newcastle, NE4 5PL
University Hospitals Plymouth NHS Trust
Plymouth, PL6 5FP
Poland4 sites
Krakowska Akademia Neurologii Sp. z o. o
Krakow, 31-505
NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki
Lodz, 90-640
Neuro-Care SP z o. o.
Siemianowice Śląskie, 41-100
Oddział Neurologii ul. L. Kondratowicza 8
Warsaw, 03-242
Czechia2 sites
Neurologicka klinika Fakutni nemocnice sv. Anny v Brne
Brno, 65691
Axon Clinical s.r.o.
Prague, 150 00
Portugal2 sites
Hospital Braga
Braga, 4710-243
CNS - Campus Neurologico Senior
Torres Vedras, 256-280
Slovakia2 sites
Nemocnica akad. L. Derera
Bratislava, 833 05
Univerzitna nemocnica L. Pasteura Kosice
Košice, 04166
About this study
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)
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.
Read the 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:
- a Screening Period;
- an open-label oral IR-LD/CD Adjustment Period;
- an open-label ND0612 Conversion Period;
- a randomized DBDD active-controlled Maintenance Period;
- an optional open-label Treatment Extension; and
- a Safety Follow-up Period.
- Conditions
- Parkinson's Disease
- Being tested
- ND0612 Solution for SC infusion, Placebo for SC infusion, Oral IR-LD/CD, Placebo for Oral IR-LD/CD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND0612 Solution for SC infusionCombination product
Levodopa/Carbidopa (LD/CD) solution administered SC via infusion pump
Placebo for SC infusionCombination product
Placebo solution administered SC via infusion pump
Oral IR-LD/CDDrug
Also called IR-LD/CD
Encapsulated LD/CD 100mg/25mg
Placebo for Oral IR-LD/CDDrug
Also called Placebo for IR-LD/CD
Encapsulated Placebo for LD/CD 100mg/25mg
| Study group | Role | What they receive |
|---|---|---|
| ND0612 Group | Experimental | ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. Receives: Combination Product: ND0612 Solution for SC infusion; Drug: Oral IR-LD/CD; Drug: Placebo for Oral IR-LD/CD |
| IR-LD/CD Group | Active comparator | 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. Receives: Combination Product: Placebo for SC infusion; Drug: Oral IR-LD/CD; Drug: Placebo for Oral IR-LD/CD |
| Oral IR-LD/CD Adjustment | Other | Active IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks. Receives: Drug: Oral IR-LD/CD |
| ND0612 Conversion | Other | ND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks. Receives: Combination Product: ND0612 Solution for SC infusion; Drug: Oral IR-LD/CD |
| Open-Label Extension | Other | ND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months. Receives: Combination Product: ND0612 Solution for SC infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to the end of DBDD Maintenance Period (12 weeks)
Secondary outcomes (1)
The change in daily OFF time
OFF time per patient diary
Measured: Baseline to the end of DBDD Maintenance Period (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start30 Sep 2019
- Primary completion1 Nov 2022
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Oral IR-LD/CD Adjustment Period - Run-in 1 (1 arm) followed by ND0612 Conversion Period - Run-in 2 (1 arm) followed by DBDD Parallel Group Maintenance Period (2 arms) followed by optional Open-label Extension Period (1 arm)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroDerm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto J Espay, MD, MSc, Principal investigator, University of Cincinnati OH, USAOlivier Rascol, MD, PhD, Principal investigator, Toulouse University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006210
- Sponsor's protocol ID
- ND0612-317
- Acronym
- BouNDless
- Status last verified
- May 2025
- First submitted
- 30 Jun 2019
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Espay AJ, Stocchi F, Pahwa R, Albanese A, Ellenbogen A, Ferreira JJ, Giladi N, Gurevich T, Hassin-Baer S, Hernandez-Vara J, Isaacson SH, Kieburtz K, LeWitt PA, Lopez-Manzanares L, Olanow CW, Poewe W, Sarva H, Yardeni T, Adar L, Salin L, Lopes N, Sasson N, Case R, Rascol O; BouNDless Study Group. Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial. Lancet Neurol. 2024 May;23(5):465-476. doi: 10.1016/S1474-4422(24)00052-8. Epub 2024 Mar 15.
PubMed 38499015
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04006210
- Acronym / sponsor ID
- BouNDless / ND0612-317
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 381 participants (actual)
- Lead sponsor
- NeuroDerm Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- a Screening Period;
- an open-label oral IR-LD/CD Adjustment Period;
- an open-label ND0612 Conversion Period;
- a randomized DBDD active-controlled Maintenance Period;
- an optional open-label Treatment Extension; and
- a Safety Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Oral IR-LD/CD Adjustment Period - Run-in 1 (1 arm) followed by ND0612 Conversion Period - Run-in 2 (1 arm) followed by DBDD Parallel Group Maintenance Period (2 arms) followed by optional Open-label Extension Period (1 arm)
| Arm | Type | Receives |
|---|---|---|
| ND0612 Group | Experimental | Combination Product: ND0612 Solution for SC infusion, Drug: Oral IR-LD/CD, Drug: Placebo for Oral IR-LD/CDND0612 continuous SC infusion + Active IR-LD/CD (grey capsules) + Placebo IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. |
| IR-LD/CD Group | Active comparator | Combination Product: Placebo for SC infusion, Drug: Oral IR-LD/CD, Drug: Placebo for Oral IR-LD/CDPlacebo for ND0612 continuous SC infusion + Placebo IR-LD/CD (grey capsules) + Active IR-LD/CD (white capsules). Randomized DBDD Maintenance Treatment for 12 weeks. |
| Oral IR-LD/CD Adjustment | Other | Drug: Oral IR-LD/CDActive IR-LD/CD (white capsules). Open-label Treatment in Run-in 1 for 4-6 weeks. |
| ND0612 Conversion | Other | Combination Product: ND0612 Solution for SC infusion, Drug: Oral IR-LD/CDND0612 continuous SC infusion + Active IR-LD/CD (grey capsules). Open-label Treatment in Run-in 2 for 4-6 weeks. |
| Open-Label Extension | Other | Combination Product: ND0612 Solution for SC infusionND0612 continuous SC infusion + Standard of care LD/dopa-decarboxylase inhibitor. Open-label Treatment in Extension for up to 54 months. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients, aged ≥30 years.
- PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
- Modified Hoehn \& Yahr score ≤3 during "ON" state.
- 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.
- 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.
Key exclusion criteria (7 listed)
- Atypical or secondary parkinsonism.
- Severe disabling dyskinesias, based on Investigator's discretion.
- Previous neurosurgery for PD.
- Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
- Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ND0612 Solution for SC infusionLevodopa/Carbidopa (LD/CD) solution administered SC via infusion pump | Combination product | ND0612 Conversion, ND0612 Group, Open-Label Extension |
| Placebo for SC infusionPlacebo solution administered SC via infusion pump | Combination product | IR-LD/CD Group |
| Oral IR-LD/CDAlso: IR-LD/CDEncapsulated LD/CD 100mg/25mg | Drug | IR-LD/CD Group, ND0612 Conversion, ND0612 Group, Oral IR-LD/CD Adjustment |
| Placebo for Oral IR-LD/CDAlso: Placebo for IR-LD/CDEncapsulated Placebo for LD/CD 100mg/25mg | Drug | IR-LD/CD Group, ND0612 Group |
Primary outcome
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
1 secondary outcome
The change in daily OFF time
Time frame: Baseline to the end of DBDD Maintenance Period (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 38499015Espay AJ, Stocchi F, Pahwa R, Albanese A, Ellenbogen A, Ferreira JJ, Giladi N, Gurevich T, Hassin-Baer S, Hernandez-Vara J, Isaacson SH, Kieburtz K, LeWitt PA, Lopez-Manzanares L, Olanow CW, Poewe W, Sarva H, Yardeni T, Adar L, Salin L, Lopes N, Sasson N, Case R, Rascol O; BouNDless Study Group. Safety and efficacy of continuous subcutaneous levodopa-carbidopa infusion (ND0612) for Parkinson's disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial. Lancet Neurol. 2024 May;23(5):465-476. doi: 10.1016/S1474-4422(24)00052-8. Epub 2024 Mar 15.
- European Union Clinical Trials RegisterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto J Espay, MD, MSc principal investigator
University of Cincinnati OH, USA
Olivier Rascol, MD, PhD principal investigator
Toulouse University Hospital, France
103 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ND0612 Solution for SC infusion and Oral IR-LD/CD in people with Parkinson's Disease, run by NeuroDerm Ltd. at 103 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in United States, Spain, Italy, France, Israel and 11 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?
This study is still under way. Results are not available in the source record yet.
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?
The change in daily ON time without troublesome dyskinesia (time frame: Baseline to the end of DBDD Maintenance Period (12 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 NCT04006210, 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 21 May 2025.