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Trial · NCT01631825

Outcomes17

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory ParametersUp to 55 weeks after dosingSafety set (SS)participantsNUMBER
SECONDARYUnified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum ScoreBaseline, Up to 54 weeks after dosingFull analysis set (FAS), last observation carried forward (LOCF)Scores on a scaleMEAN
SECONDARYUPDRS Part 2 Sum Score (Average of on State and Off State)Baseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYAbsolute Time Spent OffBaseline, up to 54 weeks after dosingFAS subjects with measurable off time at baseline, LOCFHoursMEAN
SECONDARYUPDRS Part 1 Sum ScoreBaseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYUPDRS Part 2 Sum Score (On State)Baseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYUPDRS Part 2 Sum Score (Off State)Baseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYUPDRS Part 4 Sum ScoreBaseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYTotal of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum ScoreBaseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYThe Modified Hoehn & Yahr Severity of IllnessBaseline, up to 54 weeks after dosing.FAS, LOCFPercentage of participantsNUMBER
SECONDARYEach Item of UPDRS Part 1Baseline, up to 54 weeks after dosing.FAS, LOCFPercentage of ParticipantsNUMBER
SECONDARYEach Item of UPDRS Part 2 (on State)Baseline, up to 54 weeks after dosing.FAS, LOCFPercentage of ParticipantsNUMBER
SECONDARYEach Item of UPDRS Part 2 (Off State)Baseline, up to 54 weeks after dosing.FAS, LOCFPercentage of ParticipantsNUMBER
SECONDARYEach Item of UPDRS Part 2 (Average of on State and Off State)Baseline, up to 54 weeks after dosing.FAS, LOCFPercentage of ParticipantsNUMBER
SECONDARYTotal of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)Baseline, up to 54 weeks after dosingFAS, LOCFScores on a scaleMEAN
SECONDARYEach Item of UPDRS Part 3 (on State)Baseline, up to 54 weeks after dosing.FAS, LOCFPercentage of ParticipantsNUMBER
SECONDARYEach Item of UPDRS Part 4Baseline, up to 54 weeks after dosing.FAS, LOCFPercentage of ParticipantsNUMBER

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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