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 : April 7, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750552
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|Study Director:||Medical Monitor||Theravance Biopharma|