An Observational Study of Patients With Moderate Parkinson's Disease

Part of paid clinical trials in Irvine, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT05779475
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 68 Years
Healthy Volunteers
Not accepted

Interventions

  • No treatment given — OTHER
    Participants will not receive any investigational treatment in this study.

Study Details

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.

Key Dates

Start date
Apr 5, 2023
Status verified
Dec 2025
Primary completion
Mar 11, 2030
Completion
Mar 11, 2030

Study Design

Enrollment
96 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor score) in OFF state [ Time Frame: From baseline (week 0) to end of study (13 to 104 weeks from baseline) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Joe C.Wen & Fam CTR for Adv CareIrvineCalifornia92612-
NY Presbyt Hosp-W Cornell MedNew YorkNew York10021-
NYU Langone HealthNew YorkNew York10016-

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