Trial · NCT00102596
Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor
NCT00102596, Phase 2, Completed, National Institute of Neurological Disorders and Stroke (NINDS); results first posted 2012-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor. Trials, record NCT00102596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00102596
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor
- NCT number
- NCT00102596
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Conditions
- Essential Tremor
- Interventions
- 1-Octanol
- First posted
- 2005-01-31
- Last updated
- 2012-02-01
- Results first posted
- 2012-02-01
- Limitations and caveats
- Enrollment to study was ended early, as evidence became available, that a metabolite of the study substance promised significantly higher feasibility for treatment in ET.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose | Spirography mean tremor amplitudes were measured in the right hand of each participant at 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose. Then, the scores of each participant were normalized (i.e., divided by) by their baseline tremor severity scores so that all scores are expressed as a proportion of the baseline score. Therefore, 1 is the baseline tremor severity, and lower scores indicate tremor reduction. |
| Secondary | Blood Plasma Levels of Octanoic Acid After 64 mg/kg 1-Octanol Dose | 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose | Octanoic Acid is a metabolite of 1-octanol. Blood plasma levels of octanoic acid were measured at 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose. |
| Secondary | Heart Rate Post 1-Octanol Dose | 0 minutes, 15 minutes, 100 minutes and 24 hours post-dose | |
| Secondary | PR and QTc Intervals Post 1-Octanol Dose | 0 minutes, 15 minutes, 100 minutes and 24 hours post-dose |
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 Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose | All participants who received both formulations of 64 mg/kg 1-octanol in Part B | normalized score on a scale | MEAN |
| SECONDARY | Blood Plasma Levels of Octanoic Acid After 64 mg/kg 1-Octanol Dose | 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose | All participants who received either formulation 64 mg/kg 1-octanol in Part A or B | ng/ml | MEAN |
| SECONDARY | Heart Rate Post 1-Octanol Dose | 0 minutes, 15 minutes, 100 minutes and 24 hours post-dose | All participants who received at least 1 dose of 1-octanol in Part A, B or C | beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | PR and QTc Intervals Post 1-Octanol Dose | 0 minutes, 15 minutes, 100 minutes and 24 hours post-dose | All participants who received at least 1 dose of 1-octanol in Part A, B or C | ms | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation | Normalized score at 0 minutes | 1 | Standard Error 0 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation | Normalized score at 0 minutes | 1 | Standard Error 0 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation | Normalized score at 15 minutes post-dose | 1.009 | Standard Error 0.092 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation | Normalized score at 15 minutes post-dose | 0.901 | Standard Error 0.181 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation | Normalized score at 30 minutes post-dose | 0.826 | Standard Error 0.104 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation | Normalized score at 30 minutes post-dose | 0.738 | Standard Error 0.132 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation | Normalized score at 60 minutes post-dose | 0.786 | Standard Error 0.084 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation | Normalized score at 60 minutes post-dose | 0.766 | Standard Error 0.171 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation | Normalized score at 90 minutes post-dose | 0.670 | Standard Error 0.082 | normalized score on a scale |
| Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B | 64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation | Normalized score at 90 minutes post-dose | 0.685 | Standard Error 0.16 | normalized score on a scale |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A: Dose Escalation | 11 | |
| Part A | STARTED | Part B Then C: Fixed Dose | 0 | |
| Part A | Participants Assigned Treatment | Part A: Dose Escalation | 5 | |
| Part A | Participants Assigned Treatment | Part B Then C: Fixed Dose | 0 | |
| Part A | COMPLETED | Part A: Dose Escalation | 4 | |
| Part A | COMPLETED | Part B Then C: Fixed Dose | 0 | |
| Part A | NOT COMPLETED | Part A: Dose Escalation | 7 | |
| Part A | NOT COMPLETED | Part B Then C: Fixed Dose | 0 | |
| Part B | STARTED | Part A: Dose Escalation | 0 | |
| Part B | STARTED | Part B Then C: Fixed Dose | 10 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events23
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 | Taste Change | Gastrointestinal disorders | 1-octanol Dose | 8 | 15 | 12 |
| other | Headache | General disorders | 1-octanol Dose | 5 | 15 | 10 |
| other | Heartburn | Gastrointestinal disorders | 1-octanol Dose | 5 | 15 | 7 |
| other | Gas/Bloating | Gastrointestinal disorders | 1-octanol Dose | 5 | 15 | 8 |
| other | Nausea | Gastrointestinal disorders | 1-octanol Dose | 4 | 15 | 7 |
| other | Dry Mouth | Gastrointestinal disorders | 1-octanol Dose | 4 | 15 | 6 |
| other | Constipation | Gastrointestinal disorders | 1-octanol Dose | 3 | 15 | 6 |
| other | Sedation | General disorders | 1-octanol Dose | 2 | 15 | 3 |
| other | Dizziness | General disorders | 1-octanol Dose | 2 | 15 | 5 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | 1-octanol Dose | 2 | 15 | 2 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1-octanol Dose | ||
| Total, other adverse events | 1-octanol Dose | 14 | 15 |
| Total, serious adverse events | 1-octanol Dose | 2 | 15 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00102596
GET https://conductscience.org/api/trials/v1/NCT00102596/results?page=2