Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)
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| ClinicalTrials.gov Identifier: NCT04095793 |
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Recruitment Status :
Recruiting
First Posted : September 19, 2019
Last Update Posted : November 18, 2020
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Sponsor:
Theravance Biopharma
Information provided by (Responsible Party):
Theravance Biopharma
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Symptomatic Neurogenic Orthostatic Hypotension | Drug: ampreloxetine | Phase 3 |
This is 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. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure |
| Actual Study Start Date : | September 19, 2019 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Orthostatic hypotension
MedlinePlus related topics:
Low Blood Pressure
| Arm | Intervention/treatment |
|---|---|
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Experimental: ampreloxetine
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
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Drug: ampreloxetine
Oral tablet, QD
Other Name: TD-9855 |
Primary Outcome Measures :
- Physical examination [ Time Frame: Baseline to Week 26 ]Number of subjects with new abnormalities reported on their physical exam.
- Neurological Examination [ Time Frame: Baseline to Week 26 ]Number of subjects with new abnormalities reported on their neurological exam.
- Vital Signs [ Time Frame: Baseline to Week 26 ]Number of subjects with clinically significant vital sign abnormalities.
- ECGs [ Time Frame: Baseline to Week 26 ]Number of subjects with clinically significant ECG findings.
- Clinical Laboratory Tests [ Time Frame: Baseline to Week 26 ]Number of subjects with laboratory test abnormalities.
- Concomitant Medications [ Time Frame: Baseline to Week 26 ]Changes in concomitant medications
- Adverse Events (AEs) [ Time Frame: Baseline to Week 26 ]Incidence and severity of treatment-emergent adverse events
- Subject compliance to study treatment [ Time Frame: Baseline to Week 26 ]Number of subjects determined to be compliant with study medications.
- Incidence of Falls [ Time Frame: Baseline to Week 26 ]Changes in incidence of falls
- Changes from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Week 26 ]The C-SSRS is a tool designed to systematically assess and track suicidal AEs (suicidal behavior and suicidal ideation) and will be used for all visits.
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with ampreloxetine.
- The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
- The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of >4 in OHSA#1.
Exclusion Criteria:
- Subjects may not be enrolled in another clinical trial.
- Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
- Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
- Hypersensitivity to ampreloxetine or the formulation excipients.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095793
Contacts
| Contact: Theravance Biopharma Call Center | 1-855-633-8479 | medinfo@theravance.com |
Locations
Show 26 study locations
Sponsors and Collaborators
Theravance Biopharma
Investigators
| Study Director: | Medical Monitor | Theravance Biopharma |
| Responsible Party: | Theravance Biopharma |
| ClinicalTrials.gov Identifier: | NCT04095793 |
| Other Study ID Numbers: |
0171 |
| First Posted: | September 19, 2019 Key Record Dates |
| Last Update Posted: | November 18, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Theravance Biopharma:
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ampreloxetine Symptomatic Neurogenic Orthostatic Hypotension sympomatic nOH multiple symptom atrophy MSA Parkinson's disease PD pure autonomic failure PAF orthostatic hypotension |
OH 171 low blood pressure dizziness fainting blacking out lightheadedness norepinephrine hypotension OAK |
Additional relevant MeSH terms:
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Hypotension, Orthostatic Pure Autonomic Failure Hypotension Vascular Diseases Cardiovascular Diseases |
Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |