Carbidopa for the Treatment of Excessive Blood Pressure Variability

• Status: Completed
• Trial end date: 2019-05-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Carbidopa

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.