Clinical trial NCT01864525: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-05-29
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor
timeFrame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2)
Secondary outcomes:
measure: Auditory-perceptual Tremor Severity Ratings
timeFrame: Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2).
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse University & Upstate Medical University
state: New York
Study officials:
affiliation: Syracuse University
name: Soren Y Lowell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.