Trial · NCT02579473
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety - Adverse Events and Serious Adverse Events | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in frequency of adverse events (AEs) and serious adverse events (SAEs) at the Final Safety Visit |
| Primary | Percentage of patients in each cohort who discontinued therapy due to any adverse events {Tolerability} | From initial sc dose of SER-214 up to six weeks of follow-up | Percentage of patients in each cohort who discontinued therapy due to any adverse events will be used as an assessment of tolerability |
| Primary | Safety - Vital Signs | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in assessment of vital signs (pulse, blood pressure) at each study visit and Final Safety Visit |
| Primary | Safety - Abnormal Laboratory Results | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in number of participants with laboratory test values of potential clinical importance |
| Primary | Safety - Treatment-Emergent Adverse Events | From initial sc dose of SER-214 up to six weeks of follow-up | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] will be assessed by the investigator (Yes/No). |
| Primary | Safety - ECG Changes | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in assessment of electrocardiogram (ECG) parameters at each injection visit |
| Secondary | Fluctuation index | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | On injection days plasma samples will be taken at time 0 (baseline), 1, 2, 4 and 8 hours post injection. PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the Fluctuation Index |
| Secondary | Maximum plasma concentration [C(max)] | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the C(max) |
| Secondary | Time to maximum concentration [T(max)] | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the T(max) |
| Secondary | Dose-adjusted area under the curve (AUC) | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the dose-adjusted AUC |
| Secondary | Unified Parkinson's Disease Rating Scale | From Screening up to six weeks of follow-up | The UPDRS total (Parts I, II and III) will be determined at each study site visit and the Final Safety Visit |
| Secondary | Unified Parkinson's Disease Rating Scale - Motor Part III Only | From Screening up to six weeks of follow-up | The Motor UPDRS (Part III) will be determined as a separate outcome measure at each injection day visit |
| Secondary | Epworth Sleepiness Scale (ESS) | From Screening up to six weeks of follow-up | The ESS will be determined at Screening, first Follow-up visit, Final Safety Visit and any unscheduled visit to determine if escalating doses of SER-214 are associated with increase in somnolence |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | From Screening up to six weeks of follow-up | The C-SSRS will be determined at Screening and Final Safety Visit and any unscheduled visit. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior"). |
| Secondary | Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP) | From screening up to six weeks of follow-up | The QUIP will be assessed at Screening and on the Final Safety Visit and any unscheduled visit to determine if there is any association between Impulsive-Compulsive behavior and SER-214 dose |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02579473/registered