Carbidopa for the Treatment of Excessive Blood Pressure Variability
Completed · Phase 2 · Has a placebo group
Conditions studied: Dysautonomia, Familial, Baroreflex Failure Syndrome
In brief
The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension and normalize or reduce the exaggerated blood pressure variability in patients with familial dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or Riley-Day syndrome). Funding Source- FDA OOPD.
Key facts
- Study ID
- NCT02553265
- Run by
- NYU Langone Health
- People needed
- 22
- Starts
- 2015-09-01
- Expected to finish
- 2019-05-10
- Last updated by the study team
- 2022-02-09
Who can join
Age: 10 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients with familial dysautonomia (FD) age 10 or older
- Unstable blood pressure, defined as:
- Systolic BP standard deviation >15 mmHg
- Or coefficient of variation >15%
- Or documented episodic hypertensive peaks (>140mmHg)
- Confirmed diagnosis of FD (genetic testing)
- Providing written informed consent (or ascent) to participate in the trial
- Ability to comply with the requirements of the study procedures.
You may not qualify if…
- Patients taking monoamine oxidase (MAO)-inhibitors
- Patients taking: metoclopramide, domperidone, risperidone or other dopamine blockers
- Patients taking tricyclic antidepressants
- Patients taking neuroleptic drugs (haloperidol and chlorpromazine)
- Patients with a known hypersensitivity to any component of this drug.
- Patients with atrial fibrillation, angina or significant ECG abnormality
- Patients with significant pulmonary, cardiac, liver, renal (creatinine >2.0 mg/ml)
- Patients who have a significant abnormality on clinical examination that may, in the investigator's opinion might jeopardize their healthy participating in this trial.
- Women who are pregnant or lactating.
Where it is running
- NYU Langone Medical Center, Dyautonomia Center, Suite 9Q — New York, New York, United States
- NYU Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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