Back to search results

Observational Study for Moderate Parkinson's Disease

This study is observing people with moderate Parkinson's disease to understand how their signs and symptoms change over time. You will continue taking your usual Parkinson's medications, and your study doctor may suggest adjustments to help manage your condition better. This study does not involve any new treatments; it simply observes your health. We are looking for 96 participants between 50 and 68 years old who have been diagnosed with Parkinson's disease. The main goal is to see how your motor symptoms (movement difficulties) change from the beginning of the study until the end, which could be between 13 weeks and 2 years. The current status of this study is unclear.

Study design
This is an observational study, meaning no new treatments are given. It plans to enroll 96 participants.
What's involved
Participation will last from 3 to 24 months, with clinic visits where your Parkinson's symptoms will be evaluated. At a minimum of 2 visits, you will have 'off'-assessments, which means you will be evaluated when your medication is not at its peak effect.
Compensation
Not stated in the trial record.
Follow-up
Your motor symptoms will be assessed from the start of the study (week 0) until the end, which can be between 13 and 104 weeks (up to 2 years) from when you begin.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05779475

An Observational Study of Patients With Moderate Parkinson's Disease

Enrolling by Invitation
Not specifiedAges 50–68Observational
Novo Nordisk A/S
~96 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:No treatment given

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state
Measured over From baseline (week 0) to end of study (13 to 104 weeks from baseline)

Conditions

Parkinson Disease

Explore related trials

Parkinson Disease

NCT05779475

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clinical Neuroscience

    Cambridge, United Kingdomno site contact published

  • Joe C.Wen & Fam CTR for Adv Care

    Irvine, Californiano site contact published

  • Keio University Hospital

    Shinjuku-ku, Tokyo, Japanno site contact published

  • Neurologimottagningen Lund

    Lund, Swedenno site contact published

  • NY Presbyt Hosp-W Cornell Med

    New York, New Yorkno site contact published

  • NYU Langone Health

    New York, New Yorkno site contact published

  • Region Skane Skanes Universitetssjukhus

    Lund, Swedenno site contact published

  • University of Cambridge - Clinical Neuroscience

    Cambridge, United Kingdomno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Transparency dept. 2834 · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF stateFrom baseline (week 0) to end of study (13 to 104 weeks from baseline)

    Measured as score. MDS-UPDRS consists of 4 parts - has 65 items/questions in total. Part III assesses the motor function of the patient at the time of the visit conducted in both the OFF and ON state. Each item will receive a score ranging from 0 to 4, where 0 represents the absence of impairment and 4 represents the highest degree of impairment.