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Clinical Effect of Ampreloxetine (TD-9855) for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

NCT03750552 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2022-09-14

Study results available
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Summary

A Phase 3 study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH with up to 4 weeks of treatment.

Conditions

  • Symptomatic Neurogenic Orthostatic Hypotension

Interventions

DRUG

ampreloxetine

Oral tablet, QD

DRUG

Placebo

Oral tablet, QD

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2021-07-21
Completion
2021-07-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Canada
  • Denmark
  • Estonia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03750552 on ClinicalTrials.gov