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Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

NCT04095793 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-11-30

Study results available
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Summary

A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.

Conditions

  • Symptomatic Neurogenic Orthostatic Hypotension

Interventions

DRUG

ampreloxetine

Oral tablet, QD

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2021-11-12
Completion
2021-11-12
FDA Drug
Yes

Countries

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

Study Locations

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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 NCT04095793 on ClinicalTrials.gov