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Trial · NCT05122650

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline to Week 12 on the TETRAS Composite Outcome Score as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The primary outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS assessment.score on a scaleMEAN
SECONDARYPercentage of Participants Who Improved (≥ 1-Point Improvement) From Baseline to Week 12 on the Clinical Global Impression- Severity Scale (CGI-S)Change from baseline to week 12Inferential analysis results were based on multiple imputations (impute missing values) on all study populationPercentage of participantsNUMBER
SECONDARYProportion of Participants Reported as Much Improved on the Clinical Global Impression of Change (CGI-C) at Week 12Week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 CGI-C assessment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYProportion of Participants Reported as Much Improved on the Patient Global Impression of Change (PGI-C) at Week 12Change from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 PGI-C assessment.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline to Week 12 on the TETRAS-ADL Subscale as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS-ADL assessment.score on a scaleMEAN
SECONDARYChange From Baseline to Week 12 on the TETRAS-PS Subscale as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS-PS subscale assessment.score on a scaleMEAN
SECONDARYChange From Baseline to Week 12 on the Upper Limb Score (Item 4) of the TETRAS-PS as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 Upper limb score on the TETRAS-PS assessment.score on a scaleMEAN
SECONDARYChange From Baseline to Week 12 on the TETRAS Total Score, as Summarized by Each Dose of JZP385 and Placebo.Change from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 TETRAS Total assessment.score on a scaleMEAN
SECONDARYChange From Baseline to Week 12 on the Quality of Life in Essential Tremor Questionnaire (QUEST) as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 QUEST assessment.score on a scaleMEAN
SECONDARYChange From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score A as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 ETEA assessment.score on a scaleMEAN
SECONDARYChange From Baseline to Week 12 on the Essential Tremor Embarrassment Assessment (ETEA) Score B as Summarized by Each Dose of JZP385 and PlaceboChange from baseline to week 12The outcome was assessed in participants in the Intent to Treat (ITT) analysis population set that completed the baseline and week 12 ETEA assessment.score on a scaleMEAN

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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