A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease

NCT04658186 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: PD00532020-003265-19
• Study Type: interventional
• Target: 496
• Locations: 9 countries
• Sites: 115

Brief Summary

The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.

Conditions

Early-stage Parkinson's Disease

Keywords

Early-stage parkinson's disease; UCB0599; Phase 2; Early-stage PD

Outcome Measures

Primary Outcomes (10)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Day 0

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Day 0

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 2

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 2

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 4

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 4

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 6

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 6

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 8

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 8

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 10

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 10

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 12

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 12

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 14

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 14

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 16

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 16

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III Sum Score at Month 18

  MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD and was administered by rater (0-52 possible points). Part III contained 33 questions based on 18 items. For all questions of each part, numeric score response options linked to accepted clinical terms: 0 to 4, 0=Normal, 1=Slight, 2=Mild, 3=Moderate, 4=Severe. Total Score equals sum of Parts I, II, and III (Score: 0-236). Higher score = more severe PD symptoms.

  Month 18

Secondary Outcomes (13)

• MDS-UPDRS Part III Subscale

  Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18

• MDS-UPDRS Part III Early-stage Parkinson's Disease (ePD) Subscore on Selected Items

  Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18

• MDS-UPDRS Part II Subscale

  Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18

• MDS-UPDRS Part I Subscale

  Day 0, Months 2, 4, 6, 8, 10, 12, 14, 16, 18

• Emerging Symptoms in Participants as Measured by MDS-UPDRS Part II

  Baseline to Month 18

Study Arms (3)

UCB0599 High Dose Arm

EXPERIMENTAL

Participants will be randomized to receive a predefined high dosage of UCB0599 during the Treatment Period.

Drug: UCB0599

Placebo Arm

PLACEBO COMPARATOR

Participants will be randomized to receive a predefined dosage of Placebo during the Treatment Period.

Drug: Placebo

UCB0599 Low Dose Arm

EXPERIMENTAL

Participants will be randomized to receive a predefined low dosage of UCB0599 during the Treatment Period.

Drug: UCB0599

Interventions

UCB0599 DRUG

Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.

UCB0599 High Dose Arm; UCB0599 Low Dose Arm

Placebo DRUG

Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period.

Placebo Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent
• Study participant has Parkinson's Disease (PD), with a diagnosis made by a neurologist according to the 2015 Movement Disorder Society criteria within 2 years of Baseline Visit (including diagnosis during Screening)
• The following diagnostic criteria must be met: bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor
• A Screening Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT), or a historical DaT-SPECT within 3 months of the Screening Visit that has been qualified by the central reader, shows evidence of dopamine transporter deficit per study requirements and as determined by a central reader
• Study participant is in the ≤2.5 modified Hoehn and Yahr stage at Screening
• Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require starting symptomatic treatment (ST) with a high likelihood in the next 6 months as far as clinical judgement allows
• Study participant has never taken part in disease-modifying treatment studies directed at neurodegenerative disease (NDD)
• Study participant does not take N-acetyl cysteine or other cysteine donors or glutathione precursors on a regular basis as a food supplement
• Study participant is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection
• Study participant has a body mass index (BMI) of 16 to 34kg/m² (inclusive)
• Contraception i) A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose ofstudy medication and refrain from donating sperm during this period ii) A female participant is eligible to participate if she is not pregnant, not breastfeeding, andat least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of study medication. The study participant must have a negative serum pregnancy test at Screening, which is to be confirmed negative by urine testing prior to the first dose of study medication at Baseline (Visit 3). If oral contraception is used, an additional barrier method will be required during the study as a study medication related-gastrointestinal upset or a drug interaction by CYP3A4 induction could interfere with efficacy

You may not qualify if:

• Study participant has a known hypersensitivity to any components (and/or its excipients) of the study medication or comparative drugs as stated in the protocol
• Study participant has a brain magnetic resonance imaging (MRI) scan performed during Screening indicative of a clinically significant abnormality or a historical MRI scan during the 6 months before Screening Visit 1 of sufficient quality to show such abnormalities. In case of doubt, the significance is determined on a case-by-case basis in close collaboration with the Medical Monitor and should not include abnormalities like age-appropriate brain atrophy, minor white matter signals, or mild vasculopathy
• Study participant has any contraindication for the brain MRI or Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging
• Study participant has a Montreal Cognitive Assessment (MoCA) score less than 23, indicating mild cognitive impairment or other significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation
• Study participant has abnormalities in lumbar spine previously known or determined by a Screening lumbar x-ray (if conducted) that could preclude lumbar puncture, in the opinion of the Investigator. The participant must be excluded from lumbar puncture but not from study participation
• Study participant has clinically significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator
• Study participant has past history of use of medications for the treatment of motor symptoms of PD. Short (up to 4 weeks) past use of medications for the treatment of motor symptoms is permitted following a sufficient washout period. Medications included are: levodopa (maximum 400mg per day), dopamine agonists, monoamine oxidase B (MAO-B) inhibitors, anticholinergics, or amantadine. A sufficient washout period is at least 3 months prior to the Baseline Visit

Sponsors & Collaborators

• UCB Biopharma SRL: lead
• The Parkinson Study Group: collaborator

Study Sites (115)

Pd0053 50140

Birmingham, Alabama, 35233, United States

Location

Pd0053 50506

Phoenix, Arizona, 85004-1150, United States

Location

Pd0053 50081

Phoenix, Arizona, 85013, United States

Location

Pd0053 50391

Tucson, Arizona, 85710, United States

Location

Pd0053 50539

Little Rock, Arkansas, 72205, United States

Location

Pd0053 50519

Fountain Valley, California, 92708, United States

Location

Pd0053 50385

Fresno, California, 93710, United States

Location

Pd0053 50416

La Jolla, California, 92037, United States

Location

Pd0053 50118

Los Angeles, California, 90033-5315, United States

Location

Pd0053 50531

Englewood, Colorado, 80113, United States

Location

Pd0053 50392

Danbury, Connecticut, 06810, United States

Location

Pd0053 50538

Farmington, Connecticut, 06030, United States

Location

Pd0053 50396

Boca Raton, Florida, 33486, United States

Location

Pd0053 50524

Bradenton, Florida, 34205, United States

Location

Pd0053 50199

Miami, Florida, 33136, United States

Location

Pd0053 50394

Tampa, Florida, 33613, United States

Location

Pd0053 50544

Augusta, Georgia, 30912-0004, United States

Location

Pd0053 50401

Chicago, Illinois, 60611, United States

Location

Pd0053 50310

Chicago, Illinois, 60612-3863, United States

Location

Pd0053 50399

Winfield, Illinois, 60190, United States

Location

Pd0053 50549

Iowa City, Iowa, 52242, United States

Location

Pd0053 50074

Kansas City, Kansas, 66160, United States

Location

Pd0053 50121

Lexington, Kentucky, 40536-0284, United States

Location

Pd0053 50395

New Orleans, Louisiana, 70121, United States

Location

Pd0053 50529

Baltimore, Maryland, 21201-1606, United States

Location

Pd0053 50547

Baltimore, Maryland, 21287, United States

Location

Pd0053 50243

Boston, Massachusetts, 02114, United States

Location

Pd0053 50546

Worcester, Massachusetts, 01655, United States

Location

Pd0053 50386

Farmington Hills, Michigan, 48334, United States

Location

Pd0053 50536

Saint Paul, Minnesota, 55130, United States

Location

Pd0053 50397

Las Vegas, Nevada, 89104, United States

Location

Pd0053 50299

New Brunswick, New Jersey, 08903, United States

Location

Pd0053 50077

New York, New York, 10021, United States

Location

Pd0053 50521

New York, New York, 10029, United States

Location

Pd0053 50119

New York, New York, 10032, United States

Location

Pd0053 50530

Stony Brook, New York, 11794, United States

Location

Pd0053 50535

Williamsville, New York, 14221, United States

Location

Pd0053 50372

Cleveland, Ohio, 44106, United States

Location

Pd0053 50311

Cleveland, Ohio, 44195, United States

Location

Pd0053 50255

Columbus, Ohio, 43210, United States

Location

Pd0053 50527

Toledo, Ohio, 43606, United States

Location

Pd0053 50398

Tulsa, Oklahoma, 74136, United States

Location

Pd0053 50510

Portland, Oregon, 97239, United States

Location

Pd0053 50526

Philadelphia, Pennsylvania, 19107, United States

Location

Pd0053 50084

Charleston, South Carolina, 29425, United States

Location

Pd0053 50532

Knoxville, Tennessee, 37920, United States

Location

Pd0053 50543

Memphis, Tennessee, 38157, United States

Location

Pd0053 50525

Houston, Texas, 77030-5301, United States

Location

Pd0053 50113

Houston, Texas, 77030, United States

Location

Pd0053 50400

San Antonio, Texas, 78229, United States

Location

Pd0053 50107

Burlington, Vermont, 05401-1473, United States

Location

Pd0053 50542

Charlottesville, Virginia, 22908, United States

Location

Pd0053 50410

Fairfax, Virginia, 22031, United States

Location

Pd0053 50534

Virginia Beach, Virginia, 23456, United States

Location

Pd0053 50292

Kirkland, Washington, 98034-3030, United States

Location

Pd0053 50419

Spokane, Washington, 99202, United States

Location

Pd0053 50402

Crab Orchard, West Virginia, 25827, United States

Location

Pd0053 50374

Calgary, Canada

Location

Pd0053 50390

Kelowna, Canada

Location

Pd0053 50387

Ottawa, Canada

Location

Pd0053 50389

Toronto, Canada

Location

Pd0053 40197

Amiens, France

Location

Pd0053 40527

Bordeaux, France

Location

Pd0053 40424

Créteil, France

Location

Pd0053 40526

Lille, France

Location

Pd0053 40130

Marseille, France

Location

Pd0053 40635

Nantes, France

Location

Pd0053 40524

Nîmes, France

Location

Pd0053 40525

Paris, France

Location

Pd0053 40131

Strasbourg, France

Location

Pd0053 40528

Toulouse, France

Location

Pd0053 40515

Berlin, Germany

Location

Pd0053 40138

Bonn, Germany

Location

Pd0053 40530

Dresden, Germany

Location

Pd0053 40711

Erbach im Odenwald, Germany

Location

Pd0053 40023

Erlangen, Germany

Location

Pd0053 40710

Essen, Germany

Location

Pd0053 40532

Haag in Oberbayern, Germany

Location

Pd0053 40024

Hanover, Germany

Location

Pd0053 40249

Kiel, Germany

Location

Pd0053 40174

Mainz, Germany

Location

Pd0053 40529

Marburg, Germany

Location

Pd0053 40531

Regensburg, Germany

Location

Pd0053 40555

Brescia, Italy

Location

Pd0053 40533

Padua, Italy

Location

Pd0053 40257

Roma, Italy

Location

Pd0053 40534

Roma, Italy

Location

Pd0053 40697

Roma, Italy

Location

Pd0053 40359

Nijmegen, Netherlands

Location

Pd0053 40694

Bydgoszcz, Poland

Location

Pd0053 40719

Jelenia Góra, Poland

Location

Pd0053 40539

Katowice, Poland

Location

Pd0053 40538

Krakow, Poland

Location

Pd0053 40696

Krakow, Poland

Location

Pd0053 40700

Lodz, Poland

Location

Pd0053 40702

Lublin, Poland

Location

Pd0053 40535

Oświęcim, Poland

Location

Pd0053 40536

Warsaw, Poland

Location

Pd0053 40699

Warsaw, Poland

Location

Pd0053 40705

Warsaw, Poland

Location

Pd0053 40045

A Coruña, Spain

Location

Pd0053 40159

Barcelona, Spain

Location

Pd0053 40267

Barcelona, Spain

Location

Pd0053 40046

Córdoba, Spain

Location

Pd0053 40540

Madrid, Spain

Location

Pd0053 40542

Móstoles, Spain

Location

Pd0053 40352

Pamplona, Spain

Location

Pd0053 40541

San Sebastián, Spain

Location

Pd0053 40049

Seville, Spain

Location

Pd0053 40175

London, United Kingdom

Location

Pd0053 40543

London, United Kingdom

Location

Pd0053 40698

London, United Kingdom

Location

Pd0053 40544

Motherwell, United Kingdom

Location

Pd0053 40306

Newcastle upon Tyne, United Kingdom

Location

Pd0053 40457

Plymouth, United Kingdom

Location

Related Publications (1)

• Price DL, Khan A, Angers R, Cardenas A, Prato MK, Bani M, Bonhaus DW, Citron M, Biere AL. In vivo effects of the alpha-synuclein misfolding inhibitor minzasolmin supports clinical development in Parkinson's disease. NPJ Parkinsons Dis. 2023 Jul 17;9(1):114. doi: 10.1038/s41531-023-00552-7.

  PMID: 37460603 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1-844-599-2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: December 30, 2020
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

DE (12); PL (11); ES (9); GB (6); US (57); CA (4); IT (5); NL (1); FR (10)