Trial · NCT04455555
Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease
NCT04455555, Phase 3, Completed, Peking University Third Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease. Trials, record NCT04455555. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04455555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's Disease
- NCT number
- NCT04455555
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 294 participants, actual
- Lead sponsor
- Peking University Third Hospital
- Conditions
- Parkinson's Disease
- Interventions
- LY03003( the name of rotigotine), Placebo
- First posted
- 2020-07-02
- Last updated
- 2020-07-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score | 32 weeks after treatment | Changes in the total Unified Parkinson Disease Rating Scale (UPDRS) (II +III) score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability). |
| Secondary | Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score | 32 weeks after treatment | Unified Parkinson Disease Rating Scale (UPDRS) maximum table (II +III) total score relative to baseline from baseline to the end of the double-blind dose maintenance period, The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability). |
| Secondary | changes in part II of the Unified Parkinson Disease Rating Scale relative to baseline | 32 weeks after treatment | Changes from baseline to the end of the double-blind dose maintenance period in part III of the Unified Parkinson Disease Rating Scale relative to baseline; The Unified Parkinson Disease Rating Scale scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Some sections of the Unified Parkinson Disease Rating Scale scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the Unified Parkinson Disease Rating scale represents the worst (total disability) with a score of zero representing (no disability). |
| Secondary | changes in the severity (SI) score; | 32 weeks after treatment | From baseline to the end of the double-blind dose maintenance period, changes in the severity (SI) score of Item 1 ;The Severity Score (ISS) scores ranges from 0 to 75 (i.e. Abbreviated Scale (AIS) scores of 6 for each injury in every body region according to its relative severity). If an injury is assigned an Abbreviated Injury Scale (AIS) of 6 (identified currently as untreatable injury or unsurvivable injury), the ISS score is automatically assigned 75. Since a score of 6 ("unsurvivable") indicates the futility of further medical care in preserving life, this may mean a cessation of further care in triage for a patient with a score of 6 in any category. |
| Secondary | Changes in pd Questionnaire (PDQ-8) scores | 32 weeks after treatment | Changes in pd Questionnaire (PDQ-8) scores relative to baseline from baseline to the end of the double-blind dose maintenance period; the higher the score, the worse of life quality |
| Secondary | Changes in pd sleep Disorders Scale (PDSS) score | 32 weeks after treatment | Changes in pd sleep Disorders Scale (PDSS) score from baseline to the end of the double-blind dose maintenance period. The overall PDSS is the summary score of the single PDSS items. If the single items have values between 0 (= worst case) to 10 (= best case) the total score can range between 0 and 150. Score 150 means the best case. |
| Secondary | Changes in Beck Depression Inventory II (BDI-II) scores | 32 weeks after treatment | Changes in Beck Depression Inventory II (BDI-II) scores relative to baseline from baseline to the end of the double-blind dose maintenance period. Each item of the BDI-II is rated along a 4-point Likert scale from 0 to 3； Items are summed to produce a total score（0-63） with higher scores representing more depressive symptoms. |
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/NCT04455555
GET https://conductscience.org/api/trials/v1/NCT04455555/registered