MedDataX Logo

An Observational Study of Patients With Moderate Parkinson's Disease

NCT ID: NCT05779475

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-05

Study Completion Date

2030-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main purpose of this study is to follow and observe a group of people living with Parkinson's disease to see how study participation affects their signs and symptoms in the months after starting in the study. While taking part in this study participants will take their usual medication as prescribed. However, the study doctor may recommend adjustments to their medication to provide a better treatment of their Parkinson's disease. Participation will last from 3 up to 24 months. During visits to the clinic, the study doctor or study nurse will evaluate signs and symptoms of Parkinson's disease using several different assessments. At a minimum of 2 visits participants will be asked to undergo 'off'-assessments.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants with Parkinson's disease

Participants will not receive any investigational treatment in this study. The participants will be treated with anti-Parkinson's disease medication according to local standard of care.

No treatment given

Intervention Type OTHER

Participants will not receive any investigational treatment in this study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No treatment given

Participants will not receive any investigational treatment in this study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, aged 50-68 years (both inclusive) at the time of signing informed consent.
* Diagnosed with Parkinson's disease using the Movement Disorder Society (MDS) criteria (fulfilling the definition of clinically probable Parkinson's disease).
* Moderate Parkinson's disease, e.g. as defined by i) modified Hoehn and Yahr stage 2-3 in OFF state and ii) MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score greater than or equal to (≥) 30 in OFF state, both as judged by the investigator.
* Patient has symptoms that are not adequately controlled by existing oral anti-Parkinson's disease medications, i.e., having both ON and OFF periods, as judged by the investigator.
* Parkinson's disease duration greater than (\>) 5 years and lesser than or equal to (≤) 12 years from diagnosis at the time of signing informed consent.
* Potential candidate for a future cell therapy transplantation, as judged by the investigator.
* Life expectancy \>7 years as judged by the investigator.

Exclusion Criteria

* Any atypical or secondary Parkinson's disease, or non-Parkinson's disease-suspected cause(s) of, or contributors to, parkinsonism, as judged by the investigator.
* Significant drug-induced dyskinesias as judged by the investigator, e.g., as defined by a score of \> 2 in the Abnormal Involuntary Movement Scale (AIMS), in any body part in the ON state.
* Tremor-dominant Parkinson's disease, as judged by the investigator.
* Cognitive impairment predictive of dementia (including Parkinson's disease dementia) or other cognitive dysfunction as judged by the investigator, e.g., as defined by Montreal Cognitive Assessment (MoCA) score ≤ 24, or evidence of major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) criteria.
* Major medical or psychiatric disorder (e.g., depression (Montgomery-Asberg Depression Rating Scale (MADRS) \>20) or psychosis), or other disease making the patient unsuited for participation in the study, as judged by the investigator.
* Treatment for dystonia or spasticity within 3 months of screening (Botox for a focal dystonia is allowed).
* Substantial neurological symptoms not accounted for by Parkinson's disease, including active seizure disorder, as judged by the investigator.
Minimum Eligible Age

50 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Joe C.Wen & Fam CTR for Adv Care

Irvine, California, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

NY Presbyt Hosp-W Cornell Med

New York, New York, United States

Site Status

Keio University Hospital

Shinjuku-ku, Tokyo, , Japan

Site Status

Neurologimottagningen Lund

Lund, , Sweden

Site Status

Region Skane Skanes Universitetssjukhus

Lund, , Sweden

Site Status

Clinical Neuroscience

Cambridge, , United Kingdom

Site Status

University of Cambridge - Clinical Neuroscience

Cambridge, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Japan Sweden United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1254-1741

Identifier Type: OTHER

Identifier Source: secondary_id

NN9001-4704

Identifier Type: -

Identifier Source: org_study_id