CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Carbidopa Low-Dose +2 moredrug
Likely dose
Carbidopa Low-Dose 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02553265
NCT02553265Phase 2Completed
CompareCT.gov

Carbidopa in Familial Dysautonomia: Phase-II Study, Investigational New Drug (IND) 117435, Date: 01/07/13

NYU Langone Health·interventional·Posted Sep 17, 2015·Updated Feb 9, 2022

In Brief

A Phase 2 clinical trial evaluating Carbidopa Low-Dose, Placebo, and 1 other intervention for Dysautonomia, Familial and Baroreflex Failure Syndrome. Completed, enrolled 22 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysautonomia, Familial, Baroreflex Failure Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 17, 2015
Enrollment StartSep 1, 2015
Primary CompletionMay 10, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.8 years ago

Interventions

Carbidopa Low-Dosedrug

300 mg/day

Placeboother

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

Carbidopa High-Dosedrug

600 mg/day