Phase 3 Open-Label Extension Study of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure (OAK)
|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|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2019
Last Update Posted : October 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Neurogenic Orthostatic Hypotension||Drug: ampreloxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Oral tablet, QD
Other Name: TD-9855
- 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.
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
|Study Director:||Medical Monitor||Theravance Biopharma|