Clinical TrialID 1892
Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor
NCT00848172
Essential Tremor
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1892
- Evidence Id
- 1892
- Core Evidence Id
- 1892
- Source Clinical Trial Id
- 1867
- Herb2 Clinical Trial Id
- HBCT001867
- Nct Id
- NCT00848172
- Title
- Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor
- Status
- Completed
- Phase
- Phase 1|Phase 2
- Study Result
- Yes
- Study Condition
- Essential Tremor
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Octanoic Acid|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 29
- Outcome Measure
- Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition, Postural tremor was measured using accelerometry with a motion sensor (accelerometer) placed at the dorsum of each hand, and tremor recorded simultaneously with surface-electromyography of wrist flexors and extensors for 2 minutes at each time-point. The recording was repeated with 1 lbs weight added to each wrist, which was described to record the central tremor component. The primary outcome measure was defined as tremor power of the central tremor component (after the addition of weight) 80 minutes after administration, measured at the dominant hand, normalized to baseline (baseline = 1), and comparing octanoic acid vs. placebo. Ratio of tremor power at 80 min divided by tremor power at baseline used for outcome measure calculation., 80 min after administration of the study drug on day 1 and 2 of Visit 2
- Sponsor Collaborator
- National Institute of Neurological Disorders and Stroke (NINDS)
- Funded By
- NIH
- Location
- National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
- Other Id
- 090084|09-N-0084
- Start Date
- 2009-02
- Primary Completion Date
- 2010-11
- Completion Date
- 2010-11
- First Posted
- 2009-02-20
- Results First Posted
- 2012-12-27
- Last Update Posted
- 2012-12-27
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00848172
- Title Cn
- Title En
- Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor
- Bilingual Status
- semi_complete