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NCT01961297 · ClinicalTrials.gov registry record · Phase 2
Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response
A Phase 2 study, sponsored by Kristina Simonyan.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT01961297: Completed Phase 2 study, sponsored by Kristina Simonyan.
NCT01961297 is a Phase 2 study that has completed, run by Kristina Simonyan. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01961297, a Phase 2 study, has completed, sponsored by Kristina Simonyan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The proposed research aims to determine brain abnormalities in patients with spasmodic dysphonia (SD) and voice tremor (VT) as the basis for characterization of central mechanisms underlying symptom improvement following the use of sodium oxybate, a novel oral medication for the treatment of ethanol-responsive dystonia. The proposed research is relevant to public health because the elucidation of disorder-specific mechanistic aspects of brain organization in SD vs. SD/VT is ultimately expected to lead to establishment of enhanced criteria for clinical management of these disorders, including differential diagnosis and treatment. Thus, the proposed research is relevant to the part of NIH's mission that pertains to developing fundamental knowledge that will help to reduce the burdens of human disability.
Primary Outcome
Number of participants who had reported positive effects of at least one alcohol drink on their voice symptoms
Interventions
- DRUG Sodium oxybate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-07 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 2 |
What the finished NCT01961297 record still lists
NCT01961297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium oxybate is the first listed.
NCT01961297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01961297 about?
NCT01961297 is a clinical study titled "Voice Tremor in Spasmodic Dysphonia: Central Mechanisms and Treatment Response". The proposed research aims to determine brain abnormalities in patients with spasmodic dysphonia (SD) and voice tremor (VT) as the basis for characterization of central mechanisms underlying symptom improvement following the use of sodium oxybate, a novel oral medication for the treatment of ethanol...
What is the current status of trial NCT01961297?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2012-07. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT01961297?
The interventions under investigation include: Sodium oxybate (DRUG).
Who is sponsoring clinical trial NCT01961297?
This trial is sponsored by Kristina Simonyan, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01961297's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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