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NCT02111369 · ClinicalTrials.gov registry record · Phase 4
Propranolol and Botulinum Toxin for Essential Vocal Tremor
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT02111369: Completed Phase 4 study, sponsored by Emory University.
NCT02111369 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111369, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
Essential tremor is the most common adult-onset movement disorder, and essential voice tremor is the vocal manifestation of essential tremor. While nearly all essential tremor patients experience hand tremor, many also manifest head tremor and voice tremor. Essential voice tremor can lead to increased vocal effort, decreased intelligibility, and misconstrued emotional state. Only one medication, propranolol, is FDA-approved to treat essential tremor. Propranolol is not felt to be nearly as effective for axial tremors (head, trunk, neck) as it is for extremity tremors. However, this has not been studied with any objective assessment in a prospective way for EVT. For patients with essential voice tremor, the limited published data suggests that botulinum toxin has been shown to lead to functional voice improvement. Botulinum toxin, though also not well-studied with objective voice outcomes, is a commonly used clinical therapy for treatment of essential voice tremor. While it is used more often for essential voice tremor than propranolol therapy, botulinum toxin also has not been prospectively studied with validated, objective voice outcome measures. The investigators would like to determine if propranolol has any significant effect on vocal tremor. The investigators would also like to determine, in an objective way, the effect of botulinum toxin on vocal tremor. If effective, propranolol would provide an affordable and non-invasive alternative or addition to botulinum toxin injections for patients with essential voice tremor.
Primary Outcome
The QUEST questionnaire is a 30 item self-reported essential tremor-specific quality of life scale that asks participants to rate responses (never/no, rarely, sometimes, frequently, always/yes, or not applicable). Total scores range between 0 to 100 where 0 is the best score and 100 is the worst score. A higher score indicates a lower quality of life.
Interventions
- DRUG Propranolol
- PROCEDURE Botulinum Toxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT02111369 record still lists
NCT02111369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Propranolol is the first listed.
NCT02111369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02111369 about?
NCT02111369 is a clinical study titled "Propranolol and Botulinum Toxin for Essential Vocal Tremor". Essential tremor is the most common adult-onset movement disorder, and essential voice tremor is the vocal manifestation of essential tremor. While nearly all essential tremor patients experience hand tremor, many also manifest head tremor and voice tremor. Essential voice tremor can lead to increas...
What is the current status of trial NCT02111369?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2014-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02111369?
The interventions under investigation include: Propranolol (DRUG), Botulinum Toxin (PROCEDURE).
Who is sponsoring clinical trial NCT02111369?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02111369's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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