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Trial · NCT02542696

Outcomes19

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYEvaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phaseup to approximately 3 yearsBased on Long Term Safety Full Analysis SetParticipantsCOUNT_OF_PARTICIPANTS
SECONDARY
The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries.
Week 24Based on the number of subjects who provided data at the specified timepoint in the analysis populationpercentage of instancesMEAN
SECONDARY
The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 36 Visit (LTS V5) of the LTS Phase Based on the Home Dosing Diary Entries.
Week 36Based on the number of subjects who provided data at the specified timepoint in the analysis populationpercentage of instancesMEAN
SECONDARY
The Percentage of Instances Where a Full ON Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 48 Visit (LTS V6) of the LTS Phase Based on the Home Dosing Diary Entries.
Week 48Based on the number of subjects who provided data at the specified timepoint in the analysis populationpercentage of instancesMEAN
SECONDARYPercentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 24 Visit (LTS V4) of the LTS Phase.Week 24Based on the number of subjects who provided data at the specified timepoint in the analysis populationpercent of participantsNUMBER
SECONDARYPercentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 36 Visit (LTS V5) of the LTS Phase.Week 36Based on the number of subjects who provided data at the specified timepoint in the analysis populationpercent of participantsNUMBER
SECONDARYPercentage of Subjects With a Subject-rated Full ON Response Within 30 Minutes at Week 48 Visit (LTS V6) of the LTS Phase.Week 48Based on the number of subjects who provided data at the specified timepoint in the analysis populationpercent of participantsNUMBER
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.Week 24, 15 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.Week 24, 30 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.Week 24, 60 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase.Week 24, 90 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.Week 36, 15 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.Week 36, 30 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.Week 36, 60 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase.Week 36, 90 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.Week 48, 15 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.Week 48, 30 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.Week 48, 60 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits on a scaleMEAN
SECONDARYMean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase.Week 48, 90 mins after dosingBased on the number of subjects who provided data at the specified timepoint in the analysis populationUnits 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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