AzTrials
AzTrials

Parkinson's DiseasePhase 2BeyoNDNCT02726386

A Long Term Safety Study of ND0612 Administered as a Continuous SC Infusion in Advanced Parkinson's Disease

A Phase 2 study testing ND0612 in people with Parkinson's Disease, run by NeuroDerm Ltd. at 57 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease (PD). 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
57 sitesin 9 countries
Study dates
4 May 2016to Feb 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Cohort 1.
  • Subject is able to, and has signed an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form (ICF).
  • Subject has completed the treatment period of study ND0612H-006 not more than one month prior to enrolling in ND0612H-012.
  • Willing and able to administer the SC infusion alone or with the assistance of a study partner and able to comply with the study specific procedures.
  • Cohort 2.
  • Male and female PD subjects of any race aged at least 30 years who sign an IRB/EC-approved ICF.
Show all 18Show fewer
  • PD diagnosis consistent with the UK Brain Bank Criteria.
  • Modified Hoehn \& Yahr scale in "ON" state of stage ≤3.
  • Taking at least 4 doses/day of LD/DDI (or at least 3 doses/day of Rytary) and taking, or have attempted to take, at least one other PD treatment for at least 30 days.
  • Subjects must be stable on their anti-PD medications for at least 30 days before Day 1.
  • Subjects may have had prior exposure to SC apomorphine injections/infusion but must have stopped continuous apomorphine administration at least 4 weeks before the screening visit. Treatment with apomorphine is prohibited during the entire ND0612 treatment period.
  • Must have a minimum of 2 hrs of "OFF" time per day with predictable early morning "OFF" periods as estimated by the subject.
  • Must have predictable and well defined early morning "OFF" periods with a good response to LD for treatment of the early morning "OFF" in the judgement of the investigator.
  • Mini Mental State Examination (MMSE) score ≥26.
  • No clinically significant medical, psychiatric or laboratory abnormalities which the investigator judges would be unsafe or non-compliant in the study.
  • Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), postmenopausal (defined as cessation of menses for at least 1 year), or willing to practice a highly effective method of contraception. All female participants must be non-lactating and non-pregnant and have a negative urine pregnancy test at Screening and at Baseline. Female subjects of childbearing potential must practice a highly effective method of contraception (e.g., oral contraceptives, intrauterine devices, partner with vasectomy), 1 month before enrollment, for the duration of the study, and 3 months after the last dose of study drug. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active, the subject and sexual partner must comply with the contraceptive requirements detailed above.
  • Willing and able to administer the SC infusion alone or with the assistance of a study partner after a screening period of up to 40 days and willing and able to comply with study requirements.
  • Subjects should have a named study partner.

Who cannot join

  • Cohort 1 and 2. Previously unable to tolerate ND0612 and/or have experienced intolerable adverse drug reactions associated with its use, regardless of the dosing regimen administered.
  • Cohort 2.
  • Atypical or secondary parkinsonism.
  • Acute psychosis or hallucinations in past 6 months.
  • Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
  • Any malignancy in the 5 years prior to randomization (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated).
Show all 12Show fewer
  • Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the Screening visit.
  • Prior neurosurgical procedure for PD, or Duodopa treatment
  • Subjects with a history of drug abuse or alcoholism within the past 12 months.
  • Clinically significant ECG rhythm abnormalities.
  • Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.3 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
  • Current participation in a clinical trial with an investigational product or past participation within the last 30 days before Day 1.

Trial locations and contacts

57 sites in 9 countries.

57 sites in 9 countries

United States26 sites

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • University of Maryland, Neurology

    Baltimore, Maryland, 21201

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

    Boca Raton, Florida, 33486-2359

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Unity Point Health

    Des Moines, Iowa, 50309

  • Rocky Mountain Movement Disorders Center

    Englewood, Colorado, 80113-2776

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • The Parkinsons and Movement Disorder Institute

    Fountain Valley, California, 92708-5153

  • Neuro Pain Medical Center

    Fresno, California, 93710

  • MD Clinical

    Hallandale, Florida, 33009

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • University of Florida Health at Jacksonville

    Jacksonville, Florida, 32209

  • Clinical Trials Inc.

    Little Rock, Arkansas, 72205-6421

  • Neurology Associates, PA

    Maitland, Florida, 32751-4723

  • Xenoscience

    Phoenix, Arizona, 85004

  • Parkinsons Disease Treatment Center of Southwest Florida

    Port Charlotte, Florida, 33980

  • Synergy Trials

    Richmond, Virginia, 23226

  • Pyramid Clinical Research

    Somerset, New Jersey, 08873-3448

  • Premier Research

    Spokane, Washington, 99202-1461

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33713-8844

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • USF Health Parkinson's Disease and Movement Disorders

    Tampa, Florida, 33613

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia, 23456-0168

  • Henry Ford Hospital

    West Bloomfield, Michigan, 48322-3013

Other trials in United States

France7 sites

  • Centre Hospitalier d'Aix

    Aix-en-Provence, 13616

  • CHU d'Amiens, Hopital Sud

    Amiens, 80054

  • Hopital Neurologique Pierre Wertheimer

    Bron, 69677

  • Hôpital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hopital Roger Salengro

    Lille, 59037

  • Hopital de la Timone

    Marseille, 13385

  • CHU de Poitiers

    Poitiers, 86021

Other trials in France

Germany6 sites

  • Kliniken Beelitz GmbH

    Beelitz-Heilstätten, 14547

  • St. Josefs Hospital

    Bochum, 44791

  • Klinikum-Bremerhaven Reinkenheide

    Bremerhaven, 27574

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

    Dresden, 1307

  • Klinik Haag

    Haag in Oberbayern, 83527

  • Universitaets-und Rehabilitationskliniken Ulm

    Ulm, 89081

Other trials in Germany

Israel5 sites

  • Barzilai MC

    Ashkelon, 7830604

  • Hadassah Medical Center, Ein-Kerem Campus

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 56520

  • Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Italy4 sites

  • University Foundation

    Chieti, 66100

  • AOU Pisa

    Pisa, 56126

  • IRCCS San Raffaele Pisana

    Rome, 00163

  • IRCCS Hospital San Camillo Venice

    Venice, 30126

Other trials in Italy

Czechia3 sites

  • NEUROHK, s.r.o.

    Choceň, 565 01

  • Clintrial s.r.o.

    Prague, 100 00

  • Vestra Clinics, s.r.o.

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Poland3 sites

  • Centrum Medyczne PLEJADY

    Krakow, 30-363

  • Krakowska Akademia Neurologii Sp. z o.o.

    Krakow, 31-505

  • Indywidualna Praktyka Lekarska prof. dr hab

    Lublin, 20-016

Other trials in Poland

Spain2 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario de la Princesa

    Madrid, 28006

Other trials in Spain

Austria1 site

  • Medical University Innsbruck

    Innsbruck, 6020

Other trials in Austria

About this study

Official title: A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease (PD).

Read the detailed description

This is a multi-center, international, open-label, safety study of ND0612, a solution of LD/CD delivered via a pump system as a continuous SC infusion in subjects with advanced PD. Two cohorts of subjects are candidates for this study: subjects who completed treatment in study ND0612H-006 within one month prior to enrollment (Cohort 1) and ND0612 naïve subjects or subjects who completed treatment in a ND0612 clinical study more than one month before screening (Cohort 2). After screening procedures and confirmation of the inclusion/exclusion criteria, subjects and their study partners will be trained and assisted at their homes during the first week of treatment on the proper operation of the pump system. One mandatory home visit will be performed during the first week and then on a monthly basis during 12-months of treatment. Subjects will return for in-clinic visits at Week 1 and at Months 1, 2, 3, 4, 6, 9, and 12 for assessment of safety and efficacy variables. Subjects will be allowed to continue with study treatment for an optional treatment extension period of up to Month 102 and the clinic visits will be performed every 3 months to assess subject long-term safety. Safety follow-up visits will occur 1, 2, and 3 months after the last SC infusion of ND0612 or after early termination.

Being tested
ND0612
Medical subject headings
Parkinson Disease

What participants receive

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

  • ND0612Drug

    Also called ND0612H

    ND0612, a solution of levodopa/carbidopa (LD/CD) delivered continuously subcutaneously (SC) via an infusion pump system

Study groups in NCT02726386
Study groupRoleWhat they receive
24-hour dosing regimenExperimentalContinuous SC infusion over 24 hours: fixed day rate of up to 0.64 mL/h for 18 hours, followed by a night rate of 0.08 mL/h for 6 hours to deliver a total daily dose of up to 720/90 mg of levodopa/carbidopa. All patients who had been previously assigned to the 24-hour group in the prior study continued on this dosing regimen; patients who had previously been assigned to the 14-hour daytime regimen were switched to the 24-hour regimen.
Receives: Drug: ND0612
16-hour dosing regimenExperimentalContinuous SC infusion for over 16 hours: fixed rate of 0.75 mL/h to deliver a total infusion dose of 720/90 mg of levodopa/carbidopa over 16 hours. The device is removed at night and patients in this group also receive a morning oral dose of levodopa/carbidopa upon awakening.
Receives: Drug: ND0612

What is being measured

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

  1. Adverse Events (Long-term Safety)

    Long-term safety (systemic and local) assessment will be based on adverse events (AEs), with a focus on adverse events of special interest (AESI), i.e., infusion site reactions, cases of hypersensitivity, polyneuropathy.

    Measured: Baseline to Month 12

  2. Percentages of Subjects Who Complete the 12-month Treatment Period or Discontinue Due to AE (Tolerability)

    Tolerability will be assessed based on the percentage of subjects that complete the 12-month treatment period of the study and the percentage of subjects who discontinue from the 12-month treatment period due to an AE.

    Measured: Baseline to Month 12

Secondary outcomes (1)

  1. Adverse Events (Long-term Safety)

    Long-term safety (systemic and local) and tolerability will be based on AEs, with a focus on AESI, i.e., infusion site reactions, cases of hypersensitivity, polyneuropathy.

    Measured: Month 12 to Month 102

Timeline

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

  1. First posted1 Apr 2016 (estimated)
  2. Study start4 May 2016
  3. Primary completion9 Sep 2019
  4. Study completionFeb 2027 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726386
Sponsor's protocol ID
ND0612H-012
Acronym
BeyoND
Status last verified
May 2025
First submitted
29 Mar 2016
Last updated
30 May 2025
Data monitoring committee
Yes

Publications

  • Poewe W, Stocchi F, Arkadir D, Ebersbach G, Ellenbogen AL, Giladi N, Isaacson SH, Kieburtz K, LeWitt P, Olanow CW, Simuni T, Thomas A, Zlotogorski A, Adar L, Case R, Oren S, Fuchs Orenbach S, Rosenfeld O, Sasson N, Yardeni T, Espay AJ; BeyoND study group. Subcutaneous Levodopa Infusion for Parkinson's Disease: 1-Year Data from the Open-Label BeyoND Study. Mov Disord. 2021 Nov;36(11):2687-2692. doi: 10.1002/mds.28758. Epub 2021 Sep 8.

    PubMed 34496081

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ND0612 in people with Parkinson's Disease, run by NeuroDerm Ltd. at 57 sites in 9 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 18 inclusion and 12 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 30 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 57 sites in United States, France, Germany, Israel, Italy and 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (Long-term Safety) (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. 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 NCT02726386, 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 30 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in