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NCT02553265 · ClinicalTrials.gov registry record · Phase 2

Carbidopa for the Treatment of Excessive Blood Pressure Variability

A Phase 2 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT02553265: Completed Phase 2 study, sponsored by NYU Langone Health.

NCT02553265 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02553265, a Phase 2 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study 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.

Primary Outcome

Adverse events defined as: a change in a patient's baseline condition including intercurrent illnesses irrespective of the relationship to carbidopa treatment. This will be monitored primarily with phone calls at weekly intervals. In addition, patients will be asked about adverse events while at the office. Patients will also fill a daily diary with a specific prompts to note any adverse events.

Interventions

  • OTHER Placebo
  • DRUG Carbidopa Low-Dose
  • DRUG Carbidopa High-Dose

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2015-09
Est. Completion 2019-05-10
Phase Phase 2
NYU Langone Health

1,164 total trials

What the finished NCT02553265 record still lists

NCT02553265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02553265 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02553265 about?

NCT02553265 is a clinical study titled "Carbidopa for the Treatment of Excessive Blood Pressure Variability". 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...

What is the current status of trial NCT02553265?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2015-09. Estimated completion is 2019-05-10.

What interventions are being tested in trial NCT02553265?

The interventions under investigation include: Placebo (OTHER), Carbidopa Low-Dose (DRUG), Carbidopa High-Dose (DRUG).

Who is sponsoring clinical trial NCT02553265?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02553265's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02553265, the US trial registry maintained by the National Library of Medicine. NCT02553265 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.