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Phase 2 N=17 Randomized Quadruple-blind Treatment

Effects of Octanoic Acid for Treatment of Essential Voice Tremor

Essential Voice Tremor · Vocal Tremor · Voice Tremor · Essential Tremor of Voice

Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor — 12.91; 13.49; 12.43; 9.35 percentage of voice signal with tremor — p=0.0216

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Octanoic acid (Drug); Inactive capsule (Drug)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Syracuse University
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor
12.91; 13.49; 12.43; 9.35; 5.57; 5.19 0.0216 sig
SECONDARY
Auditory-perceptual Tremor Severity Ratings
1.25; 1.53; 1.63; 1.19 0.7172

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01864525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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