Phase 2
N=40
Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
Neurogenic Orthostatic Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT02784535 ↗Enrolled (actual)
40
Serious AEs
2.3%
Results posted
Sep 2022
Primary outcome: Primary: Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score — 4.61; 4.17; 3.35; 3.5 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atomoxetine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the OHQ (Orthostatic Hypotension Questionnaire) Composite Score |
4.61; 4.17; 3.35; 3.5; -0.58; -0.5 | — |
| SECONDARY Change in Blood Pressure |
3.88; -2.44; -3.06; -0.94 | — |
| SECONDARY Change in Heart Rate (HR) |
79.12; 82.68 | — |
Summary
Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic hypotension are scarce and not effective. If left untreated, these patients have the highest risk of syncope, falls and fall-related injuries. The proposed study will determine the clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated with neurogenic orthostatic hypotension in patients with autonomic failure.
Eligibility Criteria
Inclusion Criteria
- 40 years old or older
- Neurogenic Orthostatic Hypotension (defined by a reduction of ≥20 mmHg drop in SBP within 3 minutes of standing, associated with impaired autonomic reflexes as assessed by autonomic function tests.
Exclusion Criteria
- Pregnancy or breastfeeding
- Hypersensitivity to atomoxetine (severe allergic reaction, rash, urticaria, anaphylaxis)
- Use of other norepinephrine transporter inhibitors such as Wellbutrin (Bupropion), Cymbalta (Duloxetine), Effexor (venlafaxine), Pristiq (desvenlafaxine), Savella (milnacipran)
- Previous history (within 14 days prior to enrollment) and current use of monoamine oxidase inhibitors
- Concomitant use of strong CYP2D6 inhibitors such as delavirdine, paroxetine, fluoxetine, quinidine
- Pre-existing sustained severe hypertension (BP ≥ 140/80 mmhg in the sitting position)
- Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >2 x upper limit of normal range)
- Impaired renal function (serum creatinine equal or more than 1.6 mg/dl)
- Myocardial infarction within 6 months prior to enrollment
- Congestive heart failure (LV hypertrophy acceptable)
- History of serious neurologic disease such as cerebral hemorrhage, or stroke
- Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Narrow-angle glaucoma
Data sourced from ClinicalTrials.gov (NCT02784535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.