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NCT07041203 · ClinicalTrials.gov registry record · Phase 1

Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor

A Phase 1 study, sponsored by Kristina Simonyan.

Not yet
Registry status
Phase 1
Development phase
8
Enrollment target

NCT07041203: Clinical Trial Phase 1 study, sponsored by Kristina Simonyan.

NCT07041203 is a Phase 1 study that has not yet begun recruiting, run by Kristina Simonyan. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07041203, a Phase 1 study, has not yet begun recruiting, sponsored by Kristina Simonyan.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

Using a comprehensive approach of clinico-behavioral testing and neuroimaging, the researchers will examine the clinical effects of the extended-release formulation of sodium oxybate on voice symptoms in spasmodic dysphonia in an open-label, proof-of-concept, dose-finding study.

Primary Outcome

The primary outcome will be the percent change from baseline in LD symptoms 60 min after each dose of drug intake

Interventions

  • DRUG sodium oxybate

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2026-10-01
Est. Completion 2027-09-30
Phase Phase 1
Kristina Simonyan

5 total trials

What is known before NCT07041203 opens enrollment

NCT07041203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

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

NCT07041203 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07041203 about?

NCT07041203 is a clinical study titled "Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor". Using a comprehensive approach of clinico-behavioral testing and neuroimaging, the researchers will examine the clinical effects of the extended-release formulation of sodium oxybate on voice symptoms in spasmodic dysphonia in an open-label, proof-of-concept, dose-finding study.

What is the current status of trial NCT07041203?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2026-10-01. Estimated completion is 2027-09-30.

What interventions are being tested in trial NCT07041203?

The interventions under investigation include: sodium oxybate (DRUG).

Who is sponsoring clinical trial NCT07041203?

This trial is sponsored by Kristina Simonyan, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07041203's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT07041203, the US trial registry maintained by the National Library of Medicine. NCT07041203 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.