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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Kristina Simonyan
Study ID
NCT07041203
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Laryngeal Dystonia
  • Spasmodic Dysphonia
  • Voice Tremor

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • sodium oxybate — DRUG
    Oral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Clinical response to sodium oxybate (Lumryz)
    Oral administration of sodium oxybate (1.5g, 2.0g, 2.5g, 3.0g)

Primary Outcome Measure

Efficacy of Lumryz [ Time Frame: Through study completion, an average of 4 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Kristina Simonyan, MD, PhD, DrMed
[email protected]
6175736016
Kristina Simonyan, MD, PhD, DrMed (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts Eye and Ear· Boston, MA

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