Clinical Effect of Ampreloxetine (TD-9855) for Treating snOH in Subjects With Primary Autonomic Failure (Sequoia Study)
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|ClinicalTrials.gov Identifier: NCT03750552|
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Neurogenic Orthostatic Hypotension||Drug: ampreloxetine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure|
|Actual Study Start Date :||January 24, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Participants randomized to ampreloxetine will receive a single, oral, daily dose of active drug for 4 weeks.
Oral tablet, QD
Other Name: TD-9855
Placebo Comparator: Placebo
Participants randomized to Placebo will receive a single, oral, daily dose of placebo for 4 weeks.
Oral tablet, QD
- Change from baseline in OHSA#1 at Week 4 [ Time Frame: Baseline to Week 4 ]Score change from baseline on Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA ). Question #1 assesses dizziness, lightheadedness, feeling faint, or feeling like you might blackout.
- Change from baseline in OHSA composite score in Weeks 1 to 4 [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]Orthostatic Hypotension Symptom Assessment (OHSA ) is an assessment of the severity of symptoms from low blood pressure.
- Change from baseline in OHDAS composite score in Weeks 1 to 4 [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
Orthostatic Hypotension Daily Activities Scale (OHDAS ) is an assessment of how low blood pressure symptoms affect daily life.
OHDAS is a 4 item assessment that uses an 11 point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference.
- PGI-C at Week 4 [ Time Frame: Week 4 ]Using the Patient Global Impression of Change (PGI-C) scale, a subject rates their total improvement compared to baseline.
- Incidence of falls [ Time Frame: Week 4 ]Incidence of patient-reported falls.
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): NCT03750552
|Contact: Theravance Biopharma Call Centerfirstname.lastname@example.org|
|Study Director:||Medical Monitor||Theravance Biopharma|