Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Early COMT Inhibition in PD | ClinicalTrials.gov |
| NCT number | NCT07917546 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 46 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Neuromed IRCCS | ClinicalTrials.gov |
| Conditions | PARKINSON DISEASE (Disorder) | ClinicalTrials.gov |
| Interventions | Opicapone 50 mg, L-DOPA/DDCI | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Wearable-Derived Daily OFF Time | Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point) | Percentage change in daily time spent in the OFF motor state from baseline to the four-week follow-up, objectively assessed using the STAT-ON wearable sensor during seven consecutive days of home-based monitoring. The device automatically classifies motor states using accelerometry-based algorithms. OFF time is expressed as a percentage of daily monitored time. The outcome is calculated as the difference between follow-up and baseline OFF time percentages, with negative values indicating a reduction in OFF time and clinical improvement. | ClinicalTrials.gov |
| Secondary | Change in Step Length Variability | Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point) | Change from baseline to Week 4 in the coefficient of variation of step length (%), measured using wearable sensors during daily-life monitoring. Lower values indicate more consistent gait performance. | ClinicalTrials.gov |
| Secondary | Change in Gait Velocity Variability | Baseline and Week 4 (7 consecutive days of wearable monitoring at each time point) | Change from baseline to Week 4 in the coefficient of variation of gait velocity (%), measured using wearable sensors during daily-life monitoring. Lower values indicate more consistent gait performance. | ClinicalTrials.gov |
| Secondary | 3. Change in MDS-UPDRS Part III Score | Baseline and Week 4 | Change from baseline to Week 4 in motor symptom severity assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Scores range from 0 to 132, with higher scores indicating greater motor impairment. | ClinicalTrials.gov |
| Secondary | Change in WOQ-19 Score | Baseline and Week 4 | Change from baseline to Week 4 in wearing-off symptoms assessed using the 19-item Wearing-Off Questionnaire. Scores range from 0 to 19, with higher scores indicating more wearing-off symptoms. | ClinicalTrials.gov |
| Secondary | Change in PDQ-8 Score | Baseline and Week 4 | Change from baseline to Week 4 in health-related quality of life assessed using the 8-item Parkinson's Disease Questionnaire. The Summary Index ranges from 0 to 100, with higher scores indicating poorer quality of life. | ClinicalTrials.gov |
| Secondary | Patient Global Impression of Change (PGI-C) | Baseline and Week 4 | Patient-reported global change in clinical condition at Week 4 compared with baseline, assessed using the Patient Global Impression of Change scale. Scores range from 1 (very much improved) to 7 (very much worse), with higher scores indicating a worse outcome. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)