Effects of Octanoic Acid for Treatment of Essential Voice Tremor

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ClinicalTrials.gov Identifier: NCT01864525

Recruitment Status : Completed

First Posted : May 29, 2013

Results First Posted : August 20, 2018

Last Update Posted : August 20, 2018

Sponsor:

Collaborator:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Information provided by (Responsible Party):

Soren Lowell, Syracuse University

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.

Condition or disease	Intervention/treatment	Phase
Essential Voice Tremor Vocal Tremor Voice Tremor Essential Tremor of Voice	Drug: Octanoic acid Drug: Inactive capsule	Phase 1 Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Octanoic Acid for Treatment of Essential Voice Tremor
Study Start Date :	July 2013
Actual Primary Completion Date :	December 22, 2016
Actual Study Completion Date :	March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Essential tremor

Drug Information available for: Sodium caprylate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Inactive capsule Participants will receive a pill/capsule with an inactive ingredient during the placebo arm of this study.	Drug: Inactive capsule Other Name: Placebo
Experimental: Octanoic acid Participants will receive a pill/capsule with octanoic acid (amount determined by the participant's weight) during the experimental arm of this study.	Drug: Octanoic acid Other Name: Caprylic acid

Outcome Measures

Primary Outcome Measures :

Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor [ Time Frame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2) ]
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 [ Time Frame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2). ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864525

Locations

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United States, New York
Syracuse University & Upstate Medical University
Syracuse, New York, United States, 13210

Sponsors and Collaborators

Syracuse University

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

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Principal Investigator:	Soren Y Lowell, PhD	Syracuse University

More Information

Publications of Results:

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.

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.

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.

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.

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.

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Responsible Party:	Soren Lowell, Assistant Professor, Communication Sciences & Disorders, Syracuse University
ClinicalTrials.gov Identifier:	NCT01864525
Other Study ID Numbers:	370955-3 1R03DC012429-01A1 ( U.S. NIH Grant/Contract )
First Posted:	May 29, 2013 Key Record Dates
Results First Posted:	August 20, 2018
Last Update Posted:	August 20, 2018
Last Verified:	July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Soren Lowell, Syracuse University:


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

Additional relevant MeSH terms:

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Tremor Essential Tremor Dyskinesias Neurologic Manifestations	Nervous System Diseases Movement Disorders Central Nervous System Diseases

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