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Trial · NCT03185481

Outcomes14

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Treatment-Emergent Adverse Events (All Causalities)Baseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Treatment-Emergent Adverse Events (Treatment Related)Baseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinically Significant Findings in Physical ExaminationBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period and had a post-baseline physical examination.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Clinically Significant Findings in Neurological ExaminationBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period and had a post-baseline neurological examination.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)Baseline to last visit after termination(up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Vital Signs Data Meeting Pre-defined CriteriaBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined CriteriaBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Electrocardiogram Data Meeting Pre-defined CriteriaBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Worsening Suicidality and New Onset SuicidalityBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)At last visitThe population for PWC-20 included participants who completed study treatment and who participated the first visit of follow-upParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline for Hauser Participant Diary Data in Daily OFF TimeBaseline, Day 21 and Day 35The study population included all participants who received at least 1 dose of study medication during the study period.HoursMEAN
SECONDARYChange From Baseline for Hauser Participant Diary Data in Daily ON Time With Troublesome DyskinesiaBaseline, Day 21 and Day 35The study population included all participants who received at least 1 dose of study medication during the study period.HoursMEAN
SECONDARYChange From Baseline for Hauser Participant Diary Data in Daily ON Time Without Troublesome DyskinesiaBaseline, Day 21 and Day 35The study population included all participants who received at least 1 dose of study medication during the study period.HoursMEAN
SECONDARYChange From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and Total ScoreBaseline to last visit after termination (up to approximately 3 months)The study population included all participants who received at least 1 dose of study medication during the study period.Units on a scaleMEDIAN

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

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.

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