AzTrials
AzTrials

Parkinson DiseasePhase 2NEULARKNCT06680830

A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

A Phase 2 study testing NEU-411 in people with Parkinson Disease and Parkinson, run by Neuron23 Inc. at 72 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
NEU-411
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
72 sitesin 6 countries
Study dates
17 Jan 2025to Jun 2028
Phase
Phase 2
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 40-80 years at time of screening, inclusive
  • Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
  • LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
  • Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5

Who cannot join

  • Secondary or atypical parkinsonian syndromes
  • Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
  • Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)
  • Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.

Trial locations and contacts

72 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Fatta B Nahab, MD, FAAN, FANA contact

650-228-2527

clinicaltrials@neuron23.com

72 sites in 6 countries

United States45 sites, 44 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87106

    Anna Tingin, 505-272-3342, atingin@salud.unm.edu

    Sarah P Richardson, MD, FAAN

    Recruiting

  • Emory University

    Atlanta, Georgia, 30329

    Brian Sperin, brian.a.sperin@emory.edu

    Stewart Factor, DO

    Recruiting

  • Augusta University

    Augusta, Georgia, 30912

    Buff Farrow, 706-721-0619, BFARROW@augusta.edu

    John Morgan, MD, PhD

    Recruiting

  • University of Colorado - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Emily Forbes, DO, 303-724-4644, Neuroresearch@cuanschutz.edu

    Emily Forbes, DO

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21201

    Victoria Davis, 410-328-4526, vdavis@som.umaryland.edu

    Joseph Savitt, MD, PhD

    Recruiting

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

    Boca Raton, Florida, 33486

    Karla Arias, 561-392-1818 ext. 2, karias@parkinsonscenter.org

    Stuart Isaacson, MD, FAAN

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Alexandra Gottlieb, 617-667-9890, agottli2@bidmc.harvard.edu

    Ludy Shih, MD, MMSc

    Recruiting

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

    Jessica Ferrall, 919-962-8852, jferrall@neurology.unc.edu

    Daniel Roque, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Robin Bulgarino, 843-792-1115, Bulgarino@musc.edu

    Christine Cooper, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22903

    Lauren Miller, 434-982-6599, FDK5DN@UVAHealth.org

    Binit Shah, MD, FAAN

    Recruiting

  • Northwestern Medical Group, Department of Neurology

    Chicago, Illinois, 60611

    Camryn Butze, 312-503-6824, camryn.butze@northwestern.edu

    Danielle N Larson, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Katherine Ambrogi, 614-688-6685, katherine.ambrogi@osumc.edu

    Ariane Park, MD, MPH

    Recruiting

  • Neurology Consultants of Dallas PA

    Dallas, Texas, 75243

    Maya Manjane, 214-750-9977 ext. 293, maya.manjane@carumresearch.com

    Nirav Pavasia, MD

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

    Nancy Virdi, 248-957-8944 ext. 1103, Nancy.Virdi@alcanzaclinical.com

    Aaron Ellenbogen, DO, MPH

    Recruiting

  • Neuro-Pain Medical Center

    Fresno, California, 93710

    Mirian Payo, 559-437-9700 ext. 305, mirianp@neuropain.com

    Perminder Bhatia, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32608

    Camille Swartz, 352-733-2429, cami.swartz@neurology.ufl.edu

    Irene Malaty, MD

    Recruiting

  • Struthers Parkinson Center

    Golden Valley, Minnesota, 55427

    Carrie Weaver, 952-993-5903, carrie.a.weaver@healthpartners.com

    Sotirios Parashos, MD, PhD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Aneesch Martin, 713-798-2606, aneesch.martin@bcm.edu

    Arjun Tarakad, MD

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Brittany Duncan, 713-486-3134, Brittany.J.Duncan@uth.tmc.edu

    Raja Mehanna, MD

    Recruiting

  • University of California, Irvine

    Irvine, California, 92697

    Rene Anguiano, 949-824-6407, renea1@hs.uci.edu

    Sanaz Attaripour Isfahani, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Emily Jackson, 913-588-0859, ejackson9@kumc.edu

    Rajesh Pahwa, MD

    Recruiting

  • EvergreenHealth

    Kirkland, Washington, 98034

    Ryuma Barnes, 425-899-5370, robarnes@evergreenhealthcare.org

    Pinky Agarwal, MD, FAAN

    Recruiting

  • Cleveland Clinic

    Las Vegas, Nevada, 89106

    Liliana Dumitrescu, 702-483-6000, DUMITRL@ccf.org

    Zoltan Mari, MD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Corisa Logan, 859-218-5076, corisa.logan@uky.edu

    John Slevin, MD, MBA

    Recruiting

  • University of Arkansas

    Little Rock, Arkansas, 72205

    Erin Hatcher, 501-214-2178, EHatcher@uams.edu

    Rohit Dhall, MD

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Diane Yang, 310-206-3356, DDYang@mednet.ucla.edu

    Jeff Bronstein, MD, PhD

    Recruiting

  • Northwell Health

    Manhasset, New York, 11030

    Nicholas Zumba, 516-472-5807, Neuroscienceresearch@northwell.edu

    Ritesh Ramdhani, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Shelby Schold, 414-955-0698, sschold@mcw.edu

    Karen Blindauer, MD

    Recruiting

  • Esperanza Clinical

    Murrieta, California, 92562

    Completed

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Haley Kling, 615-208-3974, haley.kling@vumc.org

    David Charles, MD

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

    Anna Leonard-Leumas, 504-842-0148, anna.leonardleumas@ochsner.org

    David Houghton, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai/Mount Sinai West

    New York, New York, 10019

    Ricardo Renvill, 212-844-6055, ricardo.revill@mountsinai.org

    Joohi Jimenez-Shahed, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Columbia Movement Disorders Research, 347-882-4315, mdresearch@cumc.columbia.edu

    Sheng-Han Kuo, MD

    Recruiting

  • Neurology One

    Orlando, Florida, 32825

    Carem Acosta, 407-674-1648, cacosta@neurologyone.com

    Ramon L Rodriguez, MD, FAAN

    Recruiting

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, California, 94301

    Leeana Bade, 650-394-6690, Lbade@Parkinsonscenter.org

    Salima Brillman, MD

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Brian Urbani, 215-955-2635, Brian.Urbani@jefferson.edu

    Tsao-Wei Liang, MD

    Recruiting

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

    Emily Leonard, 503-367-4719, leonarde@ohsu.edu

    Joseph Quinn, MD

    Recruiting

  • University of Rochester

    Rochester, New York, 14618

    Amy Chesire, 585-341-7500, Amy_Chesire@URMC.Rochester.edu

    Christopher Tarolli, MD

    Recruiting

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

    Koni Lopez, 512-218-1222 ext. 214, k.lopez@ctncpa.org

    Elizabeth Peckham, DO

    Recruiting

  • Sutter Neuroscience Institute

    Sacramento, California, 95816

    Sampreet Moneski, 916-887-4736, sampreet.moneski@sutterhealth.org

    Nicklesh Thakur, DO

    Recruiting

  • University of Utah Movement Division

    Salt Lake City, Utah, 84108

    Kendra Fowler, 801-581-7828, kendra.fowler@utah.edu

    Paolo Moretti, MD

    Recruiting

  • Inland Northwest Research

    Spokane, Washington, 99202

    Michael Dauer, 509-960-2818 ext. 6, mdauer@inwresearch.com

    Jason Aldred, MD

    Recruiting

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

    Serena Lowery, 623-832-0080, Serena.Lowery@Bannerhealth.com

    David Shprecher, DO

    Recruiting

  • USF Parkinson's & Movement Disorders Clinic

    Tampa, Florida, 33613

    Erica Botting, 813-974-8026, ericabotting@usf.edu

    Robert Hauser, MD, MBA, FAAN

    Recruiting

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

    Elise Gibson, 918-392-4530, mdcclinicaltrials@gmail.com

    Kevin Klos, MD

    Recruiting

Other trials in United States

Spain7 sites, 7 recruiting

  • Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces

    Barakaldo, 49003

    Naiara Azcue, +34 944881576, azkue.naiara@gmail.com

    Juan Carlos Gomez Esteban, MD, PhD

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Jorge Hernandez Vara, MD, +34 934893000 ext. 4884, jorge.hernandez@vallhebron.cat

    Jorge Hernandez Vara, MD

    Recruiting

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.

    Barcelona, 08036

    Alicia Garrido, Pla, +34 932275785, agarridop@clinic.cat

    Alicia Garrido, Pla

    Recruiting

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

    Madrid, 28006

    Lydia Lopez Manzanares, +34 915202405, lydia.lopez@salud.madrid.org

    Lydia Lopez Manzanares, MD

    Recruiting

  • Hospital Universitario HM Puerta del Sur

    Móstoles, 28938

    Patricia Vicente, +34 912673100 ext. 7988, pvicentefernandez@hmhospitales.com

    Michele Matarazzo, MD

    Recruiting

  • Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)

    San Sebastián, Donostia, 20014

    Gurutz Linazasoro, MD, +34 943002812, glinazasoro@vivebiotech.com

    Gurutz Linazasoro, MD

    Recruiting

  • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

    Seville, 41013

    Pablo Mir, MD, +34 955923039, pmir@us.es

    Pablo Mir, MD

    Recruiting

Other trials in Spain

Italy6 sites, 6 recruiting

  • IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia

    Milan, 20132

    Daniela Capilupo, +39 0226434815, capilupo.daniela@hsr.it

    Massimo Filippi, MD, Prof

    Recruiting

  • Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria

    Naples, 80138

    Teresa Del Santo, +39 3494026479, delsantoteresa@gmail.com

    Alessandro Tessitore, MD, PhD

    Recruiting

  • Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica

    Padua, 35128

    Angelo Antonini, +39 0498213607, angelo.antonini.pd@gmail.com

    Angelo Antonini, MD, PhD, Prof

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara

    Pisa, 56126

    Pierangela Riani, +39 050992567, p.riani@ao-pisa.toscana.it

    Roberta Ceravolo, MD, Prof

    Recruiting

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

    Rome, 00166

    Miriam Casali, +39 0652252311, miriam.casali@sanraffaele.it

    Fabrizio Stocchi, MD, PhD

    Recruiting

  • Fondazione Policilinico Universitario A Gemelli IRCCS

    Rome, 00168

    Flavia Torlizzi, +39 0630155633, flavia.torlizzi@policlinicogemelli.it

    Anna Rita Bentivoglio, MD, PhD

    Recruiting

Other trials in Italy

United Kingdom6 sites, 6 recruiting

  • Ninewells Hospital and Medical School - NHS Tayside

    Dundee, Scotland, DD19SY

    Justine Hudson, +44 1382423086, justine.hudson2@nhs.scot

    Esther Sammler, MD

    Recruiting

  • London North West University Healthcare NHS Trust - Northwick Park Hospital

    Harrow, HA1 3UJ

    Tabish Saifee, MBBS, FRCP, PhD, +44 020 3448 4252, LNWH-tr.Research@nhs.net

    Tabish Saifee, MBBS, FRCP, PhD

    Not yet recruiting

  • St George's Hospital, University of London

    London, England, SW17 0QT

    Francesca Morgante, MD, +44 20 8725 5403, fmorgant@sgul.ac.uk

    Francesca Morgante, MD

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, England, WC1N 3BG

    Olivia Burton, +44 20 3448 4531, olivia.burton7@NHS.net

    Huw Morris, MD, PhD

    Recruiting

  • Panthera Enfield

    London, EN3 4GS

    Karen Faulkner, +44 785 020 8085, karen.faulkner@panthera-bio.com

    Viquar Chamoun, MD

    Not yet recruiting

  • Clinical Aging Research Unit, Newcastle University

    Newcastle upon Tyne, England, NE4 5PL

    Nicola Pavese, MD, PhD, FRCP, FEAN, +44 0191 2081264, nicola.pavese@ncl.ac.uk

    Nicola Pavese, MD, PhD, FRCP, FEAN

    Recruiting

Other trials in United Kingdom

Israel4 sites, 4 recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Ilana Schlesinger, MD, Prof, 972-4-7771495, i_schles@rmc.gov.il

    Ilana Schlesinger, MD, Prof

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Yael Mimoun, 972-5-43184600, yaelmi@szmc.org.il

    Gilad Yahalom, MD, Prof

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5262000

    Adi Saar, 972-3-5304931, adi.saar@sheba.health.gov.il

    Sharon Hassin, MD, Prof

    Recruiting

  • Tel Aviv Medical Center

    Tel Aviv, 6423906

    Adi Ezra, 972-3-6974912, adil@tlvmc.gov.il

    Tanya Gurevich, MD, Prof

    Recruiting

Other trials in Israel

Poland4 sites, 4 recruiting

  • Centrum Medyczne Neuromed

    Bydgoszcz, 85-163

    Beata Lisewska, +48 696268565, lisewskabeata@gmail.com

    Pawel Lisewski, MD

    Recruiting

  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski

    Katowice, 32-600

    Katarzyna Smilowska, +48 600282870, kasia.smilowska@gmail.com

    Katarzyna Smilowska, MD, PhD

    Recruiting

  • Pro Life Medica Sp. z o. o. ETA Lublin

    Lublin, 20-412

    Dominika Tomaka, MD, +48 691485946, d.tomaka@etg-network.org

    Dominika Tomaka, MD

    Recruiting

  • Insula Badania Sp. Z o.o.

    Warsaw, 02-699

    Marta Jethon, +48 501035250, jethon2@tlen.pl

    Marta Jethon, MD

    Recruiting

Other trials in Poland

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

Read the detailed description

NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study and open-label extension (OLE) in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo.

After participants are screened for inclusion in the randomized, placebo-controlled portion of the study, approximately 150 participants will be randomized in a 1:1 allocation to NEU-411 30 mg once per day or placebo for a 52-week treatment period with a safety follow-up visit within 2 weeks after the last treatment visit. Eligible participants may enroll in the OLE and receive treatment for an additional 26 weeks.

Being tested
NEU-411, Placebo
Keywords
Early PD, Parkinsons, Parkinsons Disease, Idiopathic Parkinsons Disease, leucine-rich repeat kinase 2, PD, NEULARK, LRRK2, PARK8, de novo Parkinsons disease, Parkinson's disease
Medical subject headings
Parkinson Disease

What participants receive

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

  • NEU-411Drug

    NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity

  • PlaceboOther

    Orally-administered matched placebo

Study groups in NCT06680830
Study groupRoleWhat they receive
NEU-411ExperimentalOrally-administered NEU-411
Receives: Drug: NEU-411
PlaceboPlacebo comparatorOrally-administered matching placebo
Receives: Other: Placebo

What is being measured

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

  1. Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo

    Measured: From enrollment to the end of treatment at 52 weeks

  2. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo

    Measured: From enrollment to the end of study at 54 weeks

Secondary outcomes (1)

  1. Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Change from baseline to Week 52 in motor function/nonmotor as measured by Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Measured: 52 weeks

Timeline

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

  1. First posted8 Nov 2024
  2. Study start17 Jan 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJun 2028 (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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06680830
Sponsor's protocol ID
NEU-411-PD201
Acronym
NEULARK
Status last verified
Aug 2026
First submitted
5 Nov 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NEU-411 in people with Parkinson Disease and Parkinson, run by Neuron23 Inc. at 72 sites in 6 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Spain, Italy, United Kingdom, Israel and 1 more country. 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. Some participants in this study may receive a placebo. 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?

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?

Contact Fatta B Nahab, MD, FAAN, FANA (650-228-2527, clinicaltrials@neuron23.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo (time frame: From enrollment to the end of treatment at 52 weeks). 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 NCT06680830.

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 2 Oct 2026.

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