Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04658186 · ClinicalTrials.gov registry record · Phase 2
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
A Phase 2 study, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 2
- Development phase
- 496
- Enrollment target
NCT04658186: Completed Phase 2 study, sponsored by UCB Biopharma SRL.
NCT04658186 is a Phase 2 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 496 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (273% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04658186, a Phase 2 study, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 496 participants
- Enrollment target
Study Summary
The purpose of the study is to 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.
Primary Outcome
MDS-UPDRS is a multimodal scale. Part I assessed non-motor experiences of daily living and has 2 components (0-52 possible points). Part IA contains 6 questions and is assessed by the examiner (0-24 possible points). Part IB contains 7 questions on non-motor experiences of daily living completed by participant (0-28 possible points). Part II assessed motor experiences of daily living (0-52 possible points) and includes 13 questions completed by participant. Part III assessed motor signs of PD an
Interventions
- DRUG Placebo
- DRUG UCB0599
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 2 |
What the finished NCT04658186 record still lists
NCT04658186 is an interventional study that assigns participants to a tested intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (273% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04658186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04658186 about?
NCT04658186 is a clinical study titled "A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease". The purpose of the study is to 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.
What is the current status of trial NCT04658186?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 496 participants. The study started on 2020-12-30. Estimated completion is 2024-09-06.
What interventions are being tested in trial NCT04658186?
The interventions under investigation include: Placebo (DRUG), UCB0599 (DRUG).
Who is sponsoring clinical trial NCT04658186?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04658186's enrollment target sits among peer trials
496 75th of 2000 higher than 1,925 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05283720 · 496 participants · Phase 2
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
- NCT06417775 · 496 participants · Phase 3
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
- NCT06778447 · 496 participants · NA
Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
- NCT03175224 · 497 participants · Phase 2
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI