Early-stage Parkinson's disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: UCB0599
Product Code: UCB0599
Pharmaceutical Form: Capsule
CAS Number: 1802518-92-8
Current Sponsor code: UCB0599
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Study participant must be 40 to 70 years of age inclusive, at the time of signing the informed consent - Study participant has Parkinson’s Disease (PD), with a diagnosis made by a neurologist according to the 2015 Movement Disorder Society criteria within 2 years of Baseline Visit - The following diagnostic criteria must be met: bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor - A Screening Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) is consistent with PD as determined by a central reader - Study participant has no known personal or family history of autosomal-dominant forms of PD. - Study participant is in the =2 modified Hoehn and Yahr stage at Screening - Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require starting symptomatic treatment (ST) with a high likelihood in the next 6 months as far as clinical judgement allows - Study participant has never taken part in disease-modifying treatment studies directed at neurodegenerative disease (NDD) - Study participant is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection - A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of study medication and refrain from donating sperm during this period - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (i) Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of study medication. The study participant must have a negative serum pregnancy test at Screening (Visit 1), which is to confirmed negative by urine testing prior to the first dose of study medication at Baseline (Visit 3). If oral contraception is used, an additional barrier method will be required during the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Study participant has a known hypersensitivity to any components (and/or its excipients) of the study medication or comparative drugs as stated in the protocol -Study participant has a brain magnetic resonance imaging (MRI) scan performed during Screening indicative of a clinically significant abnormality or a historical MRI scan during the 6 months before Screening Visit 1 of sufficient quality to show such abnormalities. In case of doubt, the significance is determined on a case-by-case basis in close collaboration with the Medical Monitor and should not include abnormalities like age-appropriate brain atrophy, minor white matter signals, or mild vasculopathy - Study participant has any contraindication for the brain MRI or Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging - Study participant has a Montreal Cognitive Assessment (MoCA) score less than 23, indicating mild cognitive impairment or other significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation - Study participant has abnormalities in lumbar spine previously known or determined by a Screening lumbar x-ray (if conducted) that could preclude lumbar puncture, in the opinion of the Investigator - Study participant has clinically significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator - Study participant has past history of use of medications for the treatment of motor symptoms of PD (with the exception of short pharmacological testing for confirmation of diagnosis) or drugs with a potential PD disease modifying effect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson’s Disease (PD);Secondary Objective: - Demonstrate the superiority of UCB0599 over placebo with regard to neurodegeneration of dopaminergic neurons over 12 and 18 months in participants diagnosed with early-stage PD - Assess the effect of UCB0599 vs placebo with regard to intake of symptomatic treatment (ST) over 18 months in participants diagnosed with early-stage PD;Primary end point(s): 1. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IIIsum score;Timepoint(s) of evaluation of this end point: 1: From Baseline up to 18 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. MDS-UPDRS Part III subscale 2. MDS-UPDRS Part II subscale 3. MDS-UPDRS Part I subscale 4. Time to worsening of the disease on MDS-UPDRS Part III scale 5. Change in Montreal Cognitive Assessment (MoCA) 6. Change in Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) mean striatum specific binding ratios (SBR) 7. Time to start of symptomatic treatment (ST) 8. Symptomatic treatment intake 9. Incidence of treatment-emergent adverse events (TEAEs) 10. Incidence of serious adverse events (SAEs) 11. Incidence of TEAEs leading to participant withdrawal;Timepoint(s) of evaluation of this end point: 1-4+7+8: From Baseline up to 18 Months 5+6: From Screening up to 18 Months 10: From Screening up to 19 Months 9+11: From Baseline up to 19 Months | — |
Countries
Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed