Clinical Effect of Ampreloxetine (TD-9855) for Treating snOH in Subjects With Primary Autonomic Failure
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|ClinicalTrials.gov Identifier: NCT03750552|
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : June 20, 2019
|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 1, 2020|
|Estimated Study Completion Date :||September 1, 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.
PGI-C uses a 7 point scale ranging from 1 (very much improved) to 7 (very much worse)
- Incidence of falls [ Time Frame: Week 4 ]Incidence of patient-reported falls.
- Standing systolic blood pressure during orthostatic standing test [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]Systolic blood pressure taken during the standing portion of the orthostatic standing test.
- Change from baseline in UPDRS at Week 4 [ Time Frame: Baseline to Week 4 ]
Unified Parkinson's Disease Rating Scale (UPDRS) is a clinical rating scale for Parkinson's Disease (PD). Outcome measure only applies to subjects with PD.
UPDRS is made up of 6 parts. Only parts 2 & 3 (self evaluation of daily activities & clinician scored motor evaluation) will be measured at Week 4.
- Change from baseline in PDQ-8 at Week 4 [ Time Frame: Baseline to Week 4 ]Parkinson's Disease Questionnaire-8 (PDQ-8) is an assessment for Parkinson's Disease (PD) subjects. Outcome measure only applies to subjects with PD.
- Change from baseline in COMPASS-31 at Week 4 [ Time Frame: Baseline to Week 4 ]Composite Autonomic Symptoms Score-31 (COMPASS-31) is an assessment that provides a quantitative measure of autonomic symptoms. Outcome measure only applies to subjects with Multiple System Atrophy (MSA).
- Change from baseline in UMSARS at Week 4 [ Time Frame: Baseline to Week 4 ]Unified Multiple System Atrophy Rating Scale (UMSARS) is an assessment for Multiple System Atrophy (MSA) subjects. Outcome measure only applies to subjects with MSA.
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|
|United States, Arizona|
|St. Joseph's Hospital & Medical Center||Recruiting|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|Collaborative Neuroscience Network, LLC||Recruiting|
|Long Beach, California, United States, 90806|
|United States, Colorado|
|Colorado Springs Neurological Associates, PC||Recruiting|
|Colorado Springs, Colorado, United States, 80907|
|United States, Florida|
|Boca Raton Regional Hospital, Marcus Neuroscience Institute||Recruiting|
|Boca Raton, Florida, United States, 33486|
|Parkinson's Disease and Movement Disorders Center||Recruiting|
|Boca Raton, Florida, United States, 33486|
|Port Charlotte, Florida, United States, 33952|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|New York University Langone Health||Recruiting|
|New York, New York, United States, 10016|
|United States, North Carolina|
|Wake Forest University Baptist Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|Inland Northwest Research||Recruiting|
|Spokane, Washington, United States, 99202|
|Study Director:||Medical Monitor||Theravance Biopharma|