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TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)

NCT02705755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-09-26

Study results available
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Summary

This multiple-center, 3-part, single-blind dose escalation (Part A), randomized, double-blind (Part B), and open-label multiple dose extension (Part C) study will be conducted in male and female subjects with neurogenic orthostatic hypotension to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance.

Conditions

  • Neurogenic Orthostatic Hypotension
  • Multiple System Atrophy (MSA) With Orthostatic Hypotension
  • Pure Autonomic Failure
  • Parkinson Disease
  • Hypotension, Orthostatic
  • Orthostatic Hypotension
  • Pure Autonomic Failure With Orthostatic Hypotension
  • Parkinson Disease With Orthostatic Hypotension

Interventions

DRUG

TD-9855

Administered orally.

DRUG

Placebo

Administered orally.

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma, US, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-09
Primary Completion
2018-07-24
Completion
2018-11-28
FDA Drug
Yes

Countries

  • United States

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 NCT02705755 on ClinicalTrials.gov