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NCT03292458 · ClinicalTrials.gov registry record · Phase 2
Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor
A Phase 2 study of Spasmodic Dysphonia and Voice Tremor, sponsored by Kristina Simonyan.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
- 1
- Study location
NCT03292458: Completed Phase 2 study of Spasmodic Dysphonia and Voice Tremor, sponsored by Kristina Simonyan.
NCT03292458 is a Phase 2 study of Spasmodic Dysphonia and Voice Tremor that has completed, run by Kristina Simonyan. The registered enrollment target is 117 participants, above the 98-participant average among 7 other Spasmodic Dysphonia trials with a reported enrollment target (19% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292458, a Phase 2 study of Spasmodic Dysphonia and Voice Tremor, has completed, sponsored by Kristina Simonyan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
- 1
- Study location
Study Summary
Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.
Primary Outcome
A combined clinician-objective and patient-subjective change in visual analog scale (min-max 0-100, a higher score is the worse outcome) score of symptom severity before and after drug vs. placebo intake. For analysis, patients in groups (1) Alcohol-responsive (EtOH+) Laryngeal Dystonia and (2) Alcohol-responsive (EtOH+) Laryngeal Dystonia with Dystonic Tremor of Voice were combined into the overall EtOH+ group. For analysis, patients in groups (3) Alcohol-non-responsive (EtOH-) Laryngeal Dyst
Conditions Studied
Interventions
- DRUG Sodium Oxybate
Study Locations (1)
Massachusetts
- Massachusetts Eye and Ear - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2018-01-22 |
| Est. Completion | 2024-10-11 |
| Phase | Phase 2 |
What the finished NCT03292458 record still lists
NCT03292458 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, above the 98-participant average among 7 other Spasmodic Dysphonia trials with a reported enrollment target (19% higher).
The record links to 2 conditions, with Spasmodic Dysphonia appearing as the primary indexed condition, and to 1 intervention - of which Sodium Oxybate is the first listed.
NCT03292458 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03292458 about?
NCT03292458 is a clinical study titled "Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor". Using a comprehensive approach of clinico-behavioral testing, neuroimaging and pharmacogenetics, the researchers will examine the clinical effects of sodium oxybate and the matched placebo on voice symptoms in spasmodic dysphonia and voice tremor.
What is the current status of trial NCT03292458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2018-01-22. Estimated completion is 2024-10-11.
What conditions does trial NCT03292458 study?
This clinical trial studies the following conditions: Spasmodic Dysphonia, Voice Tremor.
What interventions are being tested in trial NCT03292458?
The interventions under investigation include: Sodium Oxybate (DRUG).
Who is sponsoring clinical trial NCT03292458?
This trial is sponsored by Kristina Simonyan, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03292458 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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