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Carbidopa for the Treatment of Excessive Blood Pressure Variability

NCT02553265 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-02-09

Study results available
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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.

Conditions

  • Dysautonomia, Familial
  • Baroreflex Failure Syndrome

Interventions

DRUG

Carbidopa Low-Dose

300 mg/day

OTHER

Placebo

A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.

DRUG

Carbidopa High-Dose

600 mg/day

Sponsors & Collaborators

Principal Investigators

  • Horacio C Kaufmann, MD · NYU School of Medicine

  • Lucy J Norcliffe-Kaufmann, PhD · NYU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-05-10
Completion
2019-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02553265 on ClinicalTrials.gov