Effects of Octanoic Acid for Treatment of Essential Voice Tremor

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Octanoic acid

Inactive capsule

About this trial

This is an interventional treatment trial for Essential Voice Tremor focused on measuring voice, tremor, essential tremor, essential voice tremor, voice treatment, octanoic acid, octanol, voice disorder, dysphonia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment
Participants show measurable voice tremor from recordings of the voice during screening appointment

Exclusion Criteria:

Participants have a diagnosis or show signs of Parkinson's Disease or another non-essential tremor movement disorder
Participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder)
Participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer
Participants have a diagnosis of diabetes mellitus
Participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study
Participants have a dependence on alcohol or allergy to alcohol
Participants are pregnant or lactating
Participants have an allergy to soy
Participants have Irritable Bowel Syndrome

Sites / Locations

Syracuse University & Upstate Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Inactive capsule

Octanoic acid

Arm Description

Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study.

Participants will receive a pill/capsule with octanoic acid (amount determined by the participant's weight) during the experimental arm of this study.

Outcomes

Primary Outcome Measures

Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor

Voice recordings were used to measure the degree of tremor in the voice. Mean post-test values for each acoustic measure were compared after the octanoic acid and placebo conditions, with and without consideration of baseline values. Mean values represent the average of two testing days. Degree of amplitude tremor shows the extent of amplitude variation as a percent of the mean signal amplitude, with lower numbers indicating less amplitude tremor. Baseline values for magnitude of amplitude tremor across all participants and conditions ranged from 4.06 to 27.09, and post-test values ranged from 1.94 to 26.02. Degree of frequency tremor shows the extent of fundamental frequency variation as a percent of the mean signal frequency, with lower numbers indicating less frequency tremor. Baseline values for magnitude of frequency tremor across all participants and conditions ranged from 1.21 to 15.31, and post-test values ranged from 0.60 to 13.86.

Secondary Outcome Measures

Auditory-perceptual Tremor Severity Ratings

Three experienced listeners independently rated each participant's voice from paired sample recordings comparing the baseline to post-test samples in randomized order for each condition. Sustained vowel and sentence-level recordings were rated, with decoded samples later analyzed for 1=better for post-test compared to baseline, 0= no difference between post-test and baseline. Maximum score for each participant was 3 (post-test was better for each of three raters). The range of possible scores was the sum of each of three raters' scores (0 to 3), with 0 indicating no difference between baseline and post-test voice tremor severity rating, and 3 indicating better voice (less tremor severity) at post-testing compared to pre-testing. Mean post-test values for task were compared for the octanoic acid and placebo conditions, and all raters were blind to which sample was a baseline versus a post-test recording, and which samples were associated with the [placebo or octanoic acid conditions.

Full Information

NCT ID

NCT01864525

First Posted

May 21, 2013

Last Updated

July 20, 2018

Sponsor

Syracuse University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT01864525

Brief Title

Effects of Octanoic Acid for Treatment of Essential Voice Tremor

Official Title

Effects of Octanoic Acid for Treatment of Essential Voice Tremor

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 22, 2016 (Actual)

Study Completion Date

March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Syracuse University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

Essential voice tremor is a neurological condition that produces a regular, shaking quality in the voice. One form of drug treatment that produces some improvement in tremor of the hands is octanoic acid, which is a food additive that is similar to alcohol. Research suggests that octanoic acid may reduce tremor in the hands/arms with few side effects and no intoxication effects. This study will determine whether octanoic acid may be useful for reducing tremor when it affects the voice. Researchers are hypothesizing that octanoic acid will reduce the effects of tremor on the voice.

Detailed Description

Background: Essential tremor of the voice produces regular shaking and hoarseness in the voice, making it difficult speech difficult to understand Several previous studies have found that octanoic acid and octanol, which are related to alcohol, can improve tremor in some people without producing many side effects and without producing intoxication Researchers are interested in determining whether octanoic acid can improve tremor that affects the voice Objectives: To determine the effects of octanoic voice using voice recordings and listener ratings of voice To determine the effects of octanoic acid on level of voice disability experienced by people with essential voice tremor

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Voice Tremor, Vocal Tremor, Voice Tremor, Essential Tremor of Voice

Keywords

voice, tremor, essential tremor, essential voice tremor, voice treatment, octanoic acid, octanol, voice disorder, dysphonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inactive capsule

Arm Type

Placebo Comparator

Arm Description

Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study.

Arm Title

Octanoic acid

Arm Type

Experimental

Arm Description

Participants will receive a pill/capsule with octanoic acid (amount determined by the participant's weight) during the experimental arm of this study.

Intervention Type

Drug

Intervention Name(s)

Octanoic acid

Other Intervention Name(s)

Caprylic acid

Intervention Type

Drug

Intervention Name(s)

Inactive capsule

Other Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor

Description

Voice recordings were used to measure the degree of tremor in the voice. Mean post-test values for each acoustic measure were compared after the octanoic acid and placebo conditions, with and without consideration of baseline values. Mean values represent the average of two testing days. Degree of amplitude tremor shows the extent of amplitude variation as a percent of the mean signal amplitude, with lower numbers indicating less amplitude tremor. Baseline values for magnitude of amplitude tremor across all participants and conditions ranged from 4.06 to 27.09, and post-test values ranged from 1.94 to 26.02. Degree of frequency tremor shows the extent of fundamental frequency variation as a percent of the mean signal frequency, with lower numbers indicating less frequency tremor. Baseline values for magnitude of frequency tremor across all participants and conditions ranged from 1.21 to 15.31, and post-test values ranged from 0.60 to 13.86.

Time Frame

Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2)

Secondary Outcome Measure Information:

Title

Auditory-perceptual Tremor Severity Ratings

Description

Three experienced listeners independently rated each participant's voice from paired sample recordings comparing the baseline to post-test samples in randomized order for each condition. Sustained vowel and sentence-level recordings were rated, with decoded samples later analyzed for 1=better for post-test compared to baseline, 0= no difference between post-test and baseline. Maximum score for each participant was 3 (post-test was better for each of three raters). The range of possible scores was the sum of each of three raters' scores (0 to 3), with 0 indicating no difference between baseline and post-test voice tremor severity rating, and 3 indicating better voice (less tremor severity) at post-testing compared to pre-testing. Mean post-test values for task were compared for the octanoic acid and placebo conditions, and all raters were blind to which sample was a baseline versus a post-test recording, and which samples were associated with the [placebo or octanoic acid conditions.

Time Frame

Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Participants have a diagnosis of essential voice tremor and show signs of tremor during the endoscopy examination (when pictures of the voice box are obtained)during screening appointment Participants show measurable voice tremor from recordings of the voice during screening appointment Exclusion Criteria: Participants have a diagnosis or show signs of Parkinson's Disease or another non-essential tremor movement disorder Participants have a diagnosis or show signs of spasmodic dysphonia (a different neurological voice disorder) Participants have a diagnosis of a severe, non-stable medical condition, such as kidney or liver failure, severe heart disease, severe lung disease, severe metabolic disease, uncontrolled hyperthyroidism, or other life-threatening disease such as active cancer Participants have a diagnosis of diabetes mellitus Participants are unable to suspend/stop a medication that they are currently taking for tremor or voice disorder for 12 weeks to complete this study Participants have a dependence on alcohol or allergy to alcohol Participants are pregnant or lactating Participants have an allergy to soy Participants have Irritable Bowel Syndrome

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soren Y Lowell, PhD

Organizational Affiliation

Syracuse University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Syracuse University & Upstate Medical University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

23408867

Citation

Haubenberger D, McCrossin G, Lungu C, Considine E, Toro C, Nahab FB, Auh S, Buchwald P, Grimes GJ, Starling J, Potti G, Scheider L, Kalowitz D, Bowen D, Carnie A, Hallett M. Octanoic acid in alcohol-responsive essential tremor: a randomized controlled study. Neurology. 2013 Mar 5;80(10):933-40. doi: 10.1212/WNL.0b013e3182840c4f. Epub 2013 Feb 13.

Results Reference

result

PubMed Identifier

21594724

Citation

Nahab FB, Wittevrongel L, Ippolito D, Toro C, Grimes GJ, Starling J, Potti G, Haubenberger D, Bowen D, Buchwald P, Dong C, Kalowitz D, Hallett M. An open-label, single-dose, crossover study of the pharmacokinetics and metabolism of two oral formulations of 1-octanol in patients with essential tremor. Neurotherapeutics. 2011 Oct;8(4):753-62. doi: 10.1007/s13311-011-0045-1.

Results Reference

result

PubMed Identifier

22454323

Citation

Nahab FB, Handforth A, Brown T, Shin C, Quesada A, Dong C, Haubenberger D, Hallett M. Octanoic acid suppresses harmaline-induced tremor in mouse model of essential tremor. Neurotherapeutics. 2012 Jul;9(3):635-8. doi: 10.1007/s13311-012-0121-1.

Results Reference

result

PubMed Identifier

15210907

Citation

Shill HA, Bushara KO, Mari Z, Reich M, Hallett M. Open-label dose-escalation study of oral 1-octanol in patients with essential tremor. Neurology. 2004 Jun 22;62(12):2320-2. doi: 10.1212/wnl.62.12.2320.

Results Reference

result

PubMed Identifier

14718713

Citation

Bushara KO, Goldstein SR, Grimes GJ Jr, Burstein AH, Hallett M. Pilot trial of 1-octanol in essential tremor. Neurology. 2004 Jan 13;62(1):122-4. doi: 10.1212/01.wnl.0000101722.95137.19.

Results Reference

result

Essential Voice Tremor, Vocal Tremor, Voice Tremor

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial