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Trial · NCT02668146

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryTremor reduction. TETRAS scale, performance sub scale.40 weeksThis scale evaluates tremor of various body parts during postures, movement and tasks. Items are scored from 0 to 4, with 4 representing highest severity. Maximum score is 64.
PrimaryTremor reduction. TETRAS scale. Activity of Daily Living subscale.40 weeksThe subject rates to what extent tremor affects activities in a 12-item, 0-to-4 scale. Maximum score is 48.
PrimaryTremor reduction. TETRAS scale. Subject Global Impression of Change.40 weeksSubjects rate the degree of change from minus 3 to plus 3.
PrimaryTremor reduction. TETRAS scale. QUEST subscale (QUality of life in Essential Tremor).40 weeks30-item questionnaire in which the subject rates on a 0 to 4 scale how much tremor affects aspects of life.
PrimarySafety. vitals;40 weeksWeight (lbs), respiration rate (rps), heart rate (bps) and blood pressure (mmhg).
PrimaryTolerability. Adverse Events.40 weeksAt each clinic and phone visit, the PI and coordinator will collect information on any adverse events. An Adverse Event will be defined as any clinically undesirable event.
PrimarySafety; laboratory testing40 weeks
At each clinic visit. Laboratory testing will be done. This will include metabolic panel (serum electrolytes, glucose (mg/dl) , creatinine (mg/dl) , calcium (mg/dl), magnesium (mg/dl), Complete Blood Count(CBC) (mg/dl), White Blood Count (WBC) (k/ul), platelets (k/ul), hepatic panel (total BILIRUBIN, Total PROTEIN, ALKALINE PHOSPHATASE, ALANINE AMINOTRANSFERASE, ASPARTATE AMINOTRANSFERASE, ALBUMIN GLUTAMYL TRANSFERASE LDH), and urinalysis.
PrimarySafety. Laboratory testing; screen visit testingscreen visitScreen Visit testing will include hemoglobin A1c (%), free thyroxin (ng/dl), and Thyroid Stimulating Hormone (TSH) (uIU/mL) . An EKG will be performed.
SecondaryTreatment effects on Daily Living (The QUEST scale to assess quality of life)40 weeks
Assess the effect of treatment on tremor-affected activities of daily living. The QUEST scale to assess quality of life in essential tremor. It is a 30-item questionnaire in which the subject rates on a 0 to 4 scale how much tremor affects aspects of life
SecondaryQOLIE changes40 weeksAssess changes in Quality Of Life (QOLIE).
SecondarySubjective assessment of global life changes40 weeksAssess subject global impression of change as a result of treatment

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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