Trial · NCT00848172

Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor

NCT00848172, Phase 1, Phase 2, Completed, National Institute of Neurological Disorders and Stroke (NINDS); results first posted 2012-12-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor. Trials, record NCT00848172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848172

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor
NCT number: NCT00848172
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 29 participants, actual
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions: Essential Tremor
Interventions: Octanoic Acid, Placebo
First posted: 2009-02-20
Last updated: 2012-12-27
Results first posted: 2012-12-27

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition	80 min after administration of the study drug on day 1 and 2 of Visit 2	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.
Secondary	Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo	300 min post dose	As described at the section for the primary outcome, normalized accelerometric tremor accelerometry was measured at other time-points to describe a time-course of effect. This stated secondary outcome compared normalized (baseline = 1) accelerometric at the last time-point 300 min post dose after OA vs Placebo. Ratios of tremor power at 300 min divided by tremor power at baseline used for outcome measure calculation.
Secondary	TMax Octanoic Acid	between 5 and 300 min post dose	Time to plasma peak OA
Secondary	PK: AUC After OA	5 to 300 min post dose	Area under the curve of PA plasma levels after administration

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition	80 min after administration of the study drug on day 1 and 2 of Visit 2	2 patients were excluded from primary outcome measure analysis because of one subject was withdrawn prior to drug administration due to an SAE, and one subject did not exhibit a central tremor component (primary measure), on the day of administration.	ratio	MEDIAN
SECONDARY	Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo	300 min post dose		ratio	MEDIAN
SECONDARY	TMax Octanoic Acid	between 5 and 300 min post dose		min	MEAN
SECONDARY	PK: AUC After OA	5 to 300 min post dose		hr*ng/ml	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition	Octanoic Acid	0.669	Inter-Quartile Range 0.489 to 1.548	ratio
Normalized Accelerometric Tremor Power, Dominant Hand, 80min After Administration, Weighted Condition	Placebo	0.798	Inter-Quartile Range 0.540 to 1.342	ratio
Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo	Octanoic Acid	0.689	Inter-Quartile Range 0.506 to 1.111	ratio
Normalized Tremor Power, 300 Min After Administration, Weighted Condition, Dominant Hand, OA vs Placebo	Placebo	1.071	Inter-Quartile Range 0.542 to 1.995	ratio
TMax Octanoic Acid	Octanoic Acid Tmax	72.8	Standard Deviation 34.3	min
PK: AUC After OA	Octanoic Acid AUC	1860.9	Standard Deviation 474.7	hr*ng/ml

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Visit 2 - Drug Administration	STARTED	Sequence OA / Placebo	10
Visit 2 - Drug Administration	STARTED	Sequence Placebo / OA	9
Visit 2 - Drug Administration	COMPLETED	Sequence OA / Placebo	10
Visit 2 - Drug Administration	COMPLETED	Sequence Placebo / OA	8
Visit 2 - Drug Administration	NOT COMPLETED	Sequence OA / Placebo	0
Visit 2 - Drug Administration	NOT COMPLETED	Sequence Placebo / OA	1
Visit 3 - Follow Up	STARTED	Sequence OA / Placebo	10
Visit 3 - Follow Up	STARTED	Sequence Placebo / OA	8
Visit 3 - Follow Up	COMPLETED	Sequence OA / Placebo	10
Visit 3 - Follow Up	COMPLETED	Sequence Placebo / OA	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	Octanoic Acid	3	18	3
other	Fatigue	General disorders	Placebo	2	19	2
other	Fatigue	General disorders	Non-drug Related	0	19	0
other	Itching	Skin and subcutaneous tissue disorders	Octanoic Acid	1	18	1
other	Itching	Skin and subcutaneous tissue disorders	Placebo	2	19	2
other	Itching	Skin and subcutaneous tissue disorders	Non-drug Related	0	19	0
other	Headache	Nervous system disorders	Octanoic Acid	2	18	2
other	Headache	Nervous system disorders	Placebo	1	19	1
other	Headache	Nervous system disorders	Non-drug Related	0	19	0
other	Pain at PICC insertion site	Injury, poisoning and procedural complications	Octanoic Acid	0	18	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Octanoic Acid
Total, all-cause mortality	Placebo
Total, all-cause mortality	Non-drug Related
Total, other adverse events	Octanoic Acid	7	18
Total, other adverse events	Placebo	7	19
Total, other adverse events	Non-drug Related	4	19
Total, serious adverse events	Octanoic Acid	0	18
Total, serious adverse events	Placebo	0	19
Total, serious adverse events	Non-drug Related	2	19

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11673328	BACKGROUND	PubMed
11746622	BACKGROUND	PubMed
15972843	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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