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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 is a Phase 2 study that has completed, run by Kristina Simonyan. The registered enrollment target is 53 participants.

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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.

Interventions

  • DRUG Sodium oxybate

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2012-07
Est. Completion 2017-06-30
Phase Phase 2

Sponsor

Kristina Simonyan

5 total trials

What the Registry Record Tells You About NCT01961297

The ClinicalTrials.gov registry entry for NCT01961297 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kristina Simonyan, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Sodium oxybate is the first listed.

NCT01961297 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.