Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT07041203
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and lifestyle considerations (see Lifestyle Considerations below) and availability for the duration of the study
3. Males and females
4. Age 21-80 years
5. Documented diagnosis of alcohol-responsive laryngeal dystonia
6. Documented positive response to immediate-release sodium oxybate (Xyrem) in prior studies
7. Willingness to adhere to the study intervention regimen
Exclusion Criteria:
1. The incapability of giving informed consent
2. Pregnancy or breastfeeding until a time when they are no longer pregnant or breastfeeding
3. Grade 2 or higher hepatic or renal dysfunction according to the NCI criteria
4. Moderate to severe congestive heart failure
5. Cognitive impairment (MoCA \< 26)
6. Past or present suicidal ideations (according to C-SSRS)
7. Alcoholism or high risk for alcohol use disorder according to the NIAAA definition and DSM-5 criteria
8. Asymptomatic presentation due to botulinum toxin treatment until the time they are fully symptomatic and are at least 3 months after the last injection
9. Increased daytime sleepiness (Epworth Sleepiness Scale (ESS\>10))
10. Past or present history of any neurological disorders (except for LD and co-occurring voice tremor), such as stroke, movement disorders, brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence.
11. Past or present history of any psychiatric problems, such as schizophrenia, major and/or bipolar depression, or obsessive-compulsive disorder
12. Current use of medication(s) affecting the central nervous system
13. Past or present history of brain and/or laryngeal surgery
14. Presence of certain tattoos, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that are not MRI comparable and/or cannot be removed for the purpose of MRI study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT07041203
Study Brief:
Protocol Section:
NCT07041203