NCT02705755

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

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

Type	Name	Description
DRUG	TD-9855	Administered orally.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2017-09-09
• Primary completion: 2018-07-24
• Completion: 2018-11-28
• First posted: 2016-03-10
• Last updated: 2022-09-26
• Results posted: 2022-09-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study