Trial · NCT06148311
Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia
NCT06148311, Phase 2, Enrolling by invitation, NYU Langone Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia. Trials, record NCT06148311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06148311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients With Familial Dysautonomia
- NCT number
- NCT06148311
- Status
- Enrolling by invitation
- Phases
- Phase 2
- Enrollment
- 15 participants, estimated
- Lead sponsor
- NYU Langone Health
- Conditions
- Familial Dysautonomia
- Interventions
- Matching placebo, Dexmedetomidine
- First posted
- 2023-11-28
- Last updated
- 2026-04-13
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with reduction of Autonomic crisis severity assessment scores (ACSAS) to ≤ 5 points | Up to 2 hours post administration | ACSAS tool will be used to measure objectively and record signs and symptoms of autonomic crisis, which includes documentation of blood pressure, heart rate, skin flushing and blotching, sweating, and behavioral changes. Scores are totaled at each timepoint (0 minutes, 15 min., 45 min., 1.5 hours, 2hr.) ranging from 0 (Normal) to 16 (most severe symptoms occurred). |
| Primary | Percentage of patients with 25% reduction in blood pressure | Up to 2 hours post administration | Patients will be monitored with a hospital-at-home (H@H) device to allow visualization of vital signs in real life. The H@H monitor (Biobeat™) is an FDA approved device and will be attached to the patient´s chest by an adhesive patch which will transmit blood pressure. Blood pressure will be monitored before taking each dose and up to 2 hours after. |
| Primary | Percentage of patients with >20% reduction in heart rate | Up to 2 hours post administration | Patients will be monitored with a hospital-at-home (H@H) device to allow visualization of vital signs in real life. The H@H monitor (Biobeat™) is an FDA approved device and will be attached to the patient´s chest by an adhesive patch which will transmit heart rate. Heart rate will be monitored before taking each dose and up to 2 hours after. |
| Primary | Percentage of patients with >50% reduction in vomiting/retching episodes | Up to 2 hours post administration | Patients will be monitored by their care givers for of episodes of vomiting/ retching before taking each dose and up to 2 hours after. |
| Secondary | Percentage of patients with ≥ 20% reduction in hospitalizations | Up to 48 months | Study team will compare historical data to number of hospitalizations occurred after taking one or more doses. |
| Secondary | Percentage of patients with ≥ 20% reduction in hospital stay duration | Up to 48 months | Study team will compare historical data to number of days during hospital stay that occurred after taking one or more doses. |
| Secondary | Percentage of patients with ≥ 30% reduction in ICU stay duration | Up to 48 months | Study team will compare historical data to number of days at the ICU that occurred after taking one or more doses. |
| Secondary | Change in number of medical complications | Baseline, up to 48 months | Study team will compare historical data to number of medical complications of hospitalizations occurred after taking one or more doses. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD007826 | Dexmedetomidine Sublingual Film for the Ambulatory Treatment of Hyperadrenergic Autonomic Crisis in Patients with Familial Dysautonomia | GONZALEZ-DUARTE BRISENO, MARIA ALEJANDRA | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | FOOD AND DRUG ADMINISTRATION | 2023 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06148311
GET https://conductscience.org/api/trials/v1/NCT06148311/registered