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Trial · NCT01485172

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor ScoreBaseline and Week 4 of the Maintenance Period (Study Week 17)
Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.
Score on a scaleLEAST_SQUARES_MEAN
SECONDARYNumber of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor ScoreBaseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedParticipantsNUMBER
SECONDARYNumber of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor ScoreBaseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedParticipantsNUMBER
SECONDARYNumber of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III CombinedBaseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedParticipantsNUMBER
SECONDARYResponder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor ScoreBaseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedPercentage of ParticipantsNUMBER
SECONDARYChange From Baseline in UPDRS Parts II and III CombinedBaseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedScores on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in UPDRS Activities of Daily LivingBaseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedScore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Total UPDRS Score (Parts I-III)Baseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedScore on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the UPDRS Part I (Mentation)Baseline and Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedScore on a scaleLEAST_SQUARES_MEAN
SECONDARYResponder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) ScaleWeek 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedPercentage of participantsNUMBER
SECONDARYPercentage of Participants Withdrawn From the Study Due to Lack of EfficacyUp to Week 4 of the Maintenance Period (Study Week 17)ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzedPercentage 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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GET https://conductscience.org/api/trials/v1/NCT01485172/outcomes