Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)

NCT02784535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-09-13

Study results available
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Summary

Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic hypotension are scarce and not effective. If left untreated, these patients have the highest risk of syncope, falls and fall-related injuries. The proposed study will determine the clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated with neurogenic orthostatic hypotension in patients with autonomic failure.

Conditions

  • Neurogenic Orthostatic Hypotension

Interventions

DRUG

Atomoxetine

norepinephrine transporter inhibitor

DRUG

Placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Cyndya A Shibao, MD · Vanderbilt University Medical Center

  • Horacio Kaufmann, MD · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2021-05-12
Completion
2023-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT02784535 on ClinicalTrials.gov