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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants Who Reported Adverse Events Related to Study Drug
Timeframe: Up to 90 days
Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study.
Timeframe: Up to 90 days
Number of Participants With Abnormal Electrocardiographic Interval Patterns
Timeframe: Up to 90 days
Average Systolic Blood Pressure Variability (Daytime)
Timeframe: up to Week 14
Highest Systolic Blood Pressure
Timeframe: Day 1 of treatment period
Systolic Blood Pressure
Timeframe: up to Week 14
Heart Rate
Timeframe: up to Week 14
Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel
Timeframe: Up to 90 days
Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters
Timeframe: Up to 90 days