Trial · NCT04571164
A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
NCT04571164, Phase 3, Completed, Luye Pharma Group Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD. Trials, record NCT04571164. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04571164
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
- NCT number
- NCT04571164
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 294 participants, actual
- Lead sponsor
- Luye Pharma Group Ltd.
- Conditions
- Parkinson Disease
- Interventions
- LY03003(Rotigotine,extended-release microspheres), Placebo,extended-release microspheres
- First posted
- 2020-09-30
- Last updated
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline to the end of the treatment period in the Unified Parkinson's Disease Rating Scale(UPDRS)part(Ⅱ+Ⅲ)Total Score | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | The proportion of patients whose total UPDRS decreased by 20、25、30percent or mors | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | UPDRS scale part Ⅱchanges relative to the baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | UPDRS scale part Ⅲchanges relative to the baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | Changes in SI scores in the Total Clinical Efficacy Rating Scale (CGI) relative to baseline,the scores of GI and EI | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | To clarify the changes in PDQ-8 questionnaire scores relative to baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | To clarify the changes in PDSS questionnaire scores relative to baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks | |
| Secondary | To clarify the changes in BDI-Ⅱquestionnaire scores relative to baseline | From baseline to the end of the double-blind dose maintenance period at 24weeks |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04571164
GET https://conductscience.org/api/trials/v1/NCT04571164/registered