Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Change from Baseline to Day 28 on the MDS-UPDRS Tremor Score as scored by the central rater	Baseline through completion of study treatment period, an average of 28 days	The MDS-UPDRS is a multi-dimensional scale that assesses the motor and non-motor impact of PD across four parts. Part I: Non-Motor Experiences of Daily Living; Part II: Motor Experiences of Daily Living; Part III: Motor Examination; and Part IV: Motor Complications.
Secondary	Change from Baseline to Day 28 on the TETRAS Activity of Daily Living subscale	Baseline through completion of study treatment period, an average of 28 days	The ADL section of TETRAS has 12 items, each rated 0, 1, 2, 3 or 4. The maximum total score is 48. Item 1 addresses speech; item 10 addresses occupational impairment; and item 12 assesses social impact. The other 9 items assess activities that are affected primarily by upper limb tremor
Secondary	Change from Baseline to Day 28 in accelerometry score	Baseline through completion of study treatment period, an average of 28 days	Accelerometry will be used to obtain quantitative measurements of tremor. The Kinesia ONE device will be placed on the index finger and worn in the clinic immediately after execution of the MDS-UPDRS and/or TETRAS performance subscale. A total of 4 tasks will be performed on the left side and then again on the right side to assess resting, postural, kinetic, and lateral wing beating tremor. Each task will be performed for 15 seconds.
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v4.0	Through study completion, an average of 12 weeks	Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.
Secondary	Changes from baseline in QTcF	Baseline through study completion, an average of 5 weeks	Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.
Secondary	Percentage of subjects who did not complete the study due to Treatment Emergent Adverse Events as assessed by CTCAE v4.0	Duration of study, an average of 12 weeks	Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period.
Secondary	Percentage of subjects with Serious Adverse Events as assessed by CTCAE v4.0	Duration of study, an average of 12 weeks	Any adverse event that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect observed in any offspring of the subject conceived during treatment with the study drug or is an important medical event.
Secondary	Percentage of subjects with Adverse Events of Special Interest as assessed by CTCAE v4.0	Duration of study, an average of 12 weeks	An adverse event of special interest is a serious adverse event as defined in Outcome 8.
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)	Screening through study completion, an average of 8 weeks	The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment. A numerical score is derived from the C-SSRS categories. The score is created at each assessment for each patient and is used for determining treatment emergence. Suicidal Ideation Score: The maximum suicidal ideation category (1-5 on the C-SSRS) present at the assessment.
Secondary	Epworth Sleepiness Scale	Baseline through completion of study treatment period, an average of 28 days	The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for 8 different situations. The scores are added together to obtain a single number.
Secondary	Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)	Screening through study completion, an average of 8 weeks	The QUIP-RS was developed to assess the severity of impulse control disorders and related behavior symptoms and to monitor changes in symptoms over time. The QUIP-RS has 4 primary questions (pertaining to commonly reported thoughts, urges/desires, and behaviors associated with impulsive control disorders), each of which is applied to 4 impulsive behaviors (compulsive gambling, buying, eating, and sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). It uses a 5-point scale to gauge the frequency of behaviors. Scores for each behavior and related disorder range from 0 to 16, with a higher score indicating greater severity (ie, frequency) of symptoms. The total QUIP-RS score for all impulsive control disorders and related disorders combined ranges from 0 to 112.
Secondary	University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ)	Screening, Baseline and Day 28, an average of 28 days	The UM-PDHQ is a 20-item clinician-administered questionnaire that is completed during a structured interview. Questions are divided into 2 groups: a quantitative group that consists of 6 questions (modality, frequency, duration, insight, emotional burden) and a qualitative group that consists of 14 questions. Scores range from 0-14.
Secondary	Hospital Anxiety and Depression Scale (HADS)	Screening and Day 28, an average of 28 days	The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress. The HADS is a 14-item scale that generates ordinal data. Seven of the items relate to anxiety, and 7 of the items relate to depression. Each item on the questionnaire is scored from 0 to 3, with individual scores ranging between 0 and 21 for either anxiety or depression.

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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