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Unknown

Oral UCB0599 for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study participant does not take N-acetyl cysteine or other cysteine donors or glutathione precursors on a regular basis as a food supplement
Study participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 19 months
Awards & highlights

Study Summary

This trial is testing a new medication for Parkinson's Disease to see if it is safe and better than the placebo at reducing symptoms over 12 to 18 months.

Who is the study for?
This trial is for people aged 40-75 with early-stage Parkinson's Disease who haven't used disease-modifying treatments or drugs for motor symptoms. They must meet specific diagnostic criteria, have a BMI of 16 to 34kg/m², and agree to contraception use. Exclusions include hypersensitivity to the drug, significant brain MRI abnormalities, low cognitive assessment scores, ECG issues, and spine problems preventing lumbar puncture.Check my eligibility
What is being tested?
The study tests UCB0599 against a placebo in slowing Parkinson's progression over 18 months. Participants will be randomly assigned to receive either the drug or placebo orally and monitored for changes in their clinical symptoms related to disease advancement.See study design
What are the potential side effects?
While not specified here, potential side effects may include gastrointestinal discomforts like nausea or diarrhea; allergic reactions; fatigue; dizziness; headaches; mood changes; sleep disturbances. The exact side effects will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not regularly take supplements like N-acetyl cysteine.
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I am between 40 and 75 years old.
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My Parkinson's disease is in the early or mid-stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 19 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 19 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III sum score
Secondary outcome measures
Change in Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) mean striatum specific binding ratios (SBR)
Incidence of TEAEs leading to participant withdrawal
Incidence of serious adverse events (SAEs)
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: UCB0599 Low Dose ArmExperimental Treatment1 Intervention
Participants will be randomized to receive a predefined low dosage of UCB0599 during the Treatment Period.
Group II: UCB0599 High Dose ArmExperimental Treatment1 Intervention
Participants will be randomized to receive a predefined high dosage of UCB0599 during the Treatment Period.
Group III: Placebo ArmPlacebo Group1 Intervention
Participants will be randomized to receive a predefined dosage of Placebo during the Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UCB0599
2019
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
20,940 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,467 Total Patients Enrolled

Media Library

UCB0599 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04658186 — Phase 2
Parkinson's Disease Research Study Groups: UCB0599 High Dose Arm, Placebo Arm, UCB0599 Low Dose Arm
Parkinson's Disease Clinical Trial 2023: UCB0599 Highlights & Side Effects. Trial Name: NCT04658186 — Phase 2
UCB0599 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04658186 — Phase 2
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04658186 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has UCB0599 been granted authorization by the FDA?

"UCB0599 holds a rating of 2 because it is in Phase 2, meaning there are some data that demonstrate its safety but no evidence yet to confirm effectiveness."

Answered by AI

Does this clinical research accept participants beyond the age of 65?

"Eligible participants for this clinical trial should be between the ages of 40 and 75. In contrast, there are 27 trials available for minors and 481 studies open to seniors past retirement age."

Answered by AI

How many subjects are being observed as part of this experiment?

"Absolutely. According to the data presented on clinicaltrials.gov, this medical trial commenced recruitment on December 30th 2020 and is open for 450 participants from 63 different sites. Furthermore, the information was last updated in November 10th 2022."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"This medical trial is seeking 450 participants aged 40 to 75, with a BMI ranging from 16-34 kg/m². All enrollees must have been recently diagnosed with Parkinson's disease according to the 2015 Movement Disorder Society criteria and passed an imaging test for dopamine transporter deficit within 3 months of enrollment. Moreover, those recruited cannot take medications for motor symptoms or partaken in any NDD research studies prior; they should also not use N-acetyl cysteine nor other related supplements as food additives on a regular basis. In regards to contraception, male patients must agree to utilize birth control during treatment and 90 days after their final dose while"

Answered by AI

Are there numerous medical centers running this experiment in the North American region?

"This study is recruiting 63 participants, with 3 distinct locations being Baltimore (Pd0053 50529), Portland (Pd0053 50510), and Houston (Pd0053 50525) along with an additional 60 sites."

Answered by AI

Are there currently opportunities to join this experiment?

"Affirmative. According to the clinicaltrials.gov records, this study is still open for enrolment and recruitment. First posted on December 30th 2020, it has most recently been updated on November 10th 2022. Approximately 450 participants are required from 63 distinct trial locations."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

To test a better drug for me and all the other PD patients.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
2020. "A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04658186.
~117 spots leftby Apr 2025
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