Effects of Octanoic Acid for Treatment of Essential Voice Tremor

Syracuse University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Voice Tremor; Vocal Tremor; Essential Tremor of Voice; Essential Voice Tremor

Treatments: Drug: Inactive capsule; Drug: Octanoic acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01864525

370955-3

1R03DC012429-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 17 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Inactive capsule

Placebo Comparator group

Description:

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

Treatment:

Drug: Inactive capsule

Octanoic acid

Experimental group

Description:

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

Treatment:

Drug: Octanoic acid