NCT05779475
An Observational Study of Patients With Moderate Parkinson's Disease
Enrolling by Invitation
Not specifiedAges 50–68ObservationalNovo 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
Where it's being run
8 sites across 5 statesNew York2
Sweden2
United Kingdom2
California1
Japan1
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
Do you actually qualify for this trial?
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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.