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NCT05779475Enrolling by invitation

An Observational Study of Patients With Moderate Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 24 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
96 (estimated)
First submitted
9 Mar 2023
Start date
5 Apr 2023
Primary completion date
11 Mar 2030
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05779475

What you commit to

  • Study type: Observational
  • Planned participants: 96
  • From 5 Apr 2023 to the primary completion date, 11 Mar 2030
  • 8 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.
  • 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.
  • Substantial neurological symptoms not accounted for by Parkinson's disease, including active seizure disorder, as judged by the investigator.

Other

  • Treatment for dystonia or spasticity within 3 months of screening (Botox for a focal dystonia is allowed).

Who the study is looking for

  • 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.

Age in the registry: 50 years to 68 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Cambridge - Clinical Neuroscience
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Clinical Neuroscience
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CambridgeUnited KingdomUnknown status
Keio University Hospital
Coordinator of this site? Confirm its status
Shinjuku-ku, TokyoJapanUnknown status
Region Skane Skanes Universitetssjukhus
Coordinator of this site? Confirm its status
LundSwedenUnknown status
Neurologimottagningen Lund
Coordinator of this site? Confirm its status
LundSwedenUnknown status
Joe C.Wen & Fam CTR for Adv Care
Coordinator of this site? Confirm its status
IrvineUnited StatesUnknown status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
NY Presbyt Hosp-W Cornell Med
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.