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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05779475
Other study ID # NN9001-4704
Secondary ID U1111-1254-1741
Status Enrolling by invitation
Phase
First received
Last updated
Start date April 5, 2023
Est. completion date October 22, 2025

Study information

Verified date January 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 96
Est. completion date October 22, 2025
Est. primary completion date October 22, 2025
Accepts healthy volunteers No
Gender All
Age group 50 Years to 68 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No treatment given
Participants will not receive any investigational treatment in this study.

Locations

Country Name City State
Japan Keio University Hospital Shinjuku-ku, Tokyo
Sweden Neurologimottagningen Lund Lund
United Kingdom Clinical Neuroscience Cambridge
United States NY Presbyt Hosp-W Cornell Med New York New York
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Japan,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state 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. From baseline (week 0) to end of study (13 to 104 weeks from baseline)
Secondary Change in MDS-UPDRS Part III (motor score) in OFF state 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. From last medication adjustment (between week 0 and week 104) to end of study (13 to 104 weeks from baseline)
Secondary Is the patient interested in being considered for participation in a cell therapy transplantation study (yes/no) Measured as count of participants At end of study (13 to 104 weeks from baseline)
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