NCT06128356|Active Not RecruitingPhase 2DMCFDA Drug
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Sponsor study identifier
interventional
5
1 country
1
Study Start
June 1, 2024
Actual (reported)Primary Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a pilot open-label study to evaluate the feasibility of conducting a clinical trial using sublingual dexmedetomidine sublingual film to treat hyperadrenergic autonomic crises in patients with Familial Dysautonomia at home. The primary aims are to examine the feasibility of performing a clinical trial using dexmedetomidine at home to terminate autonomic crisis, and refine the interventions and assessments used to evaluate autonomic crisis termination.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2023
Actual (reported)November 13, 2023
Actual (reported)June 1, 2024
Actual (reported)September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of subjects screened per month
Month 6
Number of subjects enrolled per month
Month 6
Number of completed crises treated at home within the protocol
Month 6
Number of subjects that underwent an autonomic crisis per month
Month 6
Average duration of the study from visit 1 to the last visit of the last patient
From enrollment to end of treatment (up to 6 months)
Length of time from autonomic crisis onset to the initiation of the video recording
Up to 2 hours
Length of time from autonomic crisis onset to administration of the medication
Up to 2 hours
Length of time from autonomic crisis onset to crisis resolution
Up to 24 hours
Length of time it took to complete assessments from start of autonomic crisis
Up to 24 hours
Percentage of completion of all rating scales
Month 6
Participants will be administered two 60 micrograms sublingual films of IGLMI following start of an autonomic crises. The maximum amount for the study is four oral films of 60 micrograms in 24 hours, two at the beginning of the crises and if needed, two additional within two hours.
Dexmedetomidine 120 mcg on two thin dissolvable films for sublingual administration
NYU Langone Health
New York, New York, 10016, United States
Alejandra Gonzalez-Duarte, MD
NYU Langone Health
5 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2023
First Posted
November 13, 2023
Study Start
June 1, 2024
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 4, 2026
Record last verified: 2026-03
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Alejandra.gonzalez-duarte@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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Source: ClinicalTrials.gov.
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