Trial · NCT07207057
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II combined | baseline, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination and week 165 | The rate of Parkinson's disease progression between the active treatment and placebo arms is measured by the MDS-UPDRS Parts I and II combined with equal weighting |
| Secondary | Hoehn and Yahr Scale (H&Y) | screening, week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination and week 165 | Clinician reported measures. Parkinson's disease stage is measured using the Hoehn and Yahr Scale (H\&Y) |
| Secondary | Montreal Cognitive Assessment (MoCA) | screening, week 0, week 26, week 52, week 104, week 156 or early termination. | Clinician reported measures. Cognitive impairment is measured using the Montreal Cognitive Assessment (MoCA) |
| Secondary | levodopa-equivalent daily dose (LEDD) | all study visits | Clinician reported measures. Parkinson's disease medication use is measured by levodopa-equivalent daily dose (LEDD). |
| Secondary | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Remote) | screening, week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination and week 165. | Clinician reported measures. Part III of the MDS-UPDRS in the ON medication state (remote elements only) |
| Secondary | Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV | screening, week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination and week 165 | Clinician reported measures. Part IV of the MDS-UPDRS in the ON medication state |
| Secondary | Severity of depression | screening, week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination. | Participant reported measures. The severity of depression is assessed by the Patient Health Questionnaire (PHQ-9) |
| Secondary | Quality of Life - Parkinson's Disease Questionnaire (PDQ-8) | week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination. | Participant reported measures. Quality of life is assessed by the Parkinson's Disease Questionnaire (PDQ-8) |
| Secondary | Carers' quality-of-life assessed by the questionnaire for parkinsonism (PQoL Carers) | week 0, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination. | Participant reported measures. Carers' quality-of-life is assessed by the questionnaire for parkinsonism (PQoL Carers) |
| Secondary | Ability to enjoy life (ICECAP-O) | week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination. | Participant reported measures. Ability to enjoy life is assessed by the ICEpop CAPability measure for Older people (ICECAP-O) |
| Secondary | Health-related quality of life (EQ-5D-5L) | week 0, week 13, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination. | Participant reported measures. Health-related quality of life is assessed by the EuroQol five-dimension scale questionnaire (EQ-5D-5L). Has 5 response levels (no problems, some problems, moderate problems, severe problems, extreme problems) and a visual analogue scale capturing overall health (100 means the best health you imagine; 0 means the worst health you can imagine). |
| Secondary | Use of health and social care resources | week 0, week 26, week 52, week 78, week 104, week 130 and week 156. | Participant reported measures. Use of health and social care resources is assessed by the resource use questionnaire to determine participants use of different health services and the care and support received. |
| Secondary | Carer health-related quality of life (EQ-5D-5L) | week 0, week 26, week 52, week 78, week 104, week 130, week 156 (end of study visit) or early termination. | Participant reported measures. Carer health-related quality of life is assessed by the EuroQol five-dimension scale questionnaire (EQ-5D-5L) |
| Secondary | Suicidal ideation (C-SSRS) | screening, week 156 (end of study visit) or early termination | Safety and tolerability. Suicidal ideation is assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) |
| Secondary | Adverse Events (Safety and Tolerability) | week 0, week 1, week, 2, week, 3, week 4, week 5, week 13, week 26, week 39, week 52, week 65, week 78, week 104, week 130, week 156, week 165 | Safety and tolerability. Other safety and tolerability measures are assessed through the collection of adverse events/serious adverse events, treatment compliance and trial withdrawal and treatment discontinuation rates |
| Secondary | Participant experience of trial participation | week 0, week 78, week 156 (end of study) or early termination | Participant experience before, during and after trial participation as assessed by the Study Participant Feedback Questionnaire (SPFQ), which includes written feedback and responding to statements using the responses: Strongly disagree, Disagree, Neither agree or disagree, Agree and Strongly agree. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
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