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

Parkinson Disease Clinical Trial

Official title: A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic Hypotension

Status Completed

Clinical Trial 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.

Clinical Trial Description

Part A followed a daily, single-escalating-dose design, starting with placebo on Day 1, followed by a dose of 2.5 mg TD-9855 on Day 2, and proceeding to higher daily doses of TD-9855 up to a maximum dose of 20 mg based on safety, tolerability, and determination of a pressor effect.

The starting dose in Part A was initially set to 1 mg (Day 2), escalating to a maximum dose of 10 mg (Day 5), but this was revised to start at 2.5 mg (Day 2) and escalate to 20 mg (Day 5) in protocol amendment 2 (Section 9.8.1).

Part B followed a randomized, placebo-controlled, parallel design, evaluating an acute dose of TD-9855 that was determined to have a pressor effect and to be generally well tolerated for a given subject from Part A.

Subjects who completed Part A, demonstrated a pressor effect in Part A, and remained otherwise eligible, had the option to receive open-label TD-9855 by tablet daily for up to 5 months (20 weeks) during Part C. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02705755
• Study type: Interventional
• Source: Theravance Biopharma
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2017
• Completion date: November 28, 2018