Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04095793 |
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Recruitment Status :
Terminated
(Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.)
First Posted : September 19, 2019
Results First Posted : November 30, 2022
Last Update Posted : November 30, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Symptomatic Neurogenic Orthostatic Hypotension | Drug: ampreloxetine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 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 |
| Actual Primary Completion Date : | November 12, 2021 |
| Actual Study Completion Date : | November 12, 2021 |
| 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 |
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to a maximum of 749 days ]
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus the number of days in the follow-up period.
Clinically significant abnormalities in physical and neurological examinations, vital signs, resting 12-lead electrocardiograms, and clinical laboratory evaluations, in addition to incidence of fall, suicidal ideation, and suicidal behavior, were reported as AEs.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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| Study Director: | Medical Monitor | Theravance Biopharma |
Documents provided by Theravance Biopharma:
| Responsible Party: | Theravance Biopharma |
| ClinicalTrials.gov Identifier: | NCT04095793 |
| Other Study ID Numbers: |
0171 2019-002425-30 ( EudraCT Number ) |
| First Posted: | September 19, 2019 Key Record Dates |
| Results First Posted: | November 30, 2022 |
| Last Update Posted: | November 30, 2022 |
| Last Verified: | November 2022 |
| 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 |
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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 |
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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 |