Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure

Phase 3

Terminated

• Conditions: Symptomatic Neurogenic Orthostatic Hypotension; MSA; Parkinson's Disease (PD); Pure Autonomic Failure (PAF)
• Interventions: Drug: ampreloxetine; Drug: Placebo

• Registration Number: NCT03829657
• Lead Sponsor: Theravance Biopharma

Brief Summary

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

Detailed Description

Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL) treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension safety study)).

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-04
• Study Start: 2019-02-22
• Primary Completion: 2021-11-10
• Study Completion: 2021-11-10
• Results First Submitted: 2022-11-08
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Results First Posted: 2023-01-20
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ampreloxetine	ampreloxetine	After completing the OL, participants randomized to ampreloxetine will receive single, oral, daily dose of active drug for a further 6 weeks.
ampreloxetine (Open Label (OL))	ampreloxetine	Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 16 weeks.
Placebo	Placebo	After completing the OL, participants randomized to Placebo will receive single, oral, daily dose of placebo for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period	6-week randomized withdrawal period (Week 16 to Week 22)	Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.; Least squares mean here is the model-based proportion of participants with treatment failure using logistic regression.

Trial Locations

Locations (82)

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

UC San Diego Movement Disorder Center; 🇺🇸 La Jolla, California, United States

Stanford Neuroscience Health Center; 🇺🇸 Palo Alto, California, United States

Colorado Springs Neurological Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

Parkinson's Disease and Movement Disorders Center; 🇺🇸 Boca Raton, Florida, United States

SFM Clinical Research, LLC; 🇺🇸 Boca Raton, Florida, United States

Neurostudies, Inc; 🇺🇸 Port Charlotte, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

NorthShore University Health System; 🇺🇸 Glenview, Illinois, United States

University of Kansas Medical Center Research Institute, Inc.; 🇺🇸 Kansas City, Kansas, United States

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