Norepinephrine Transporter Blockade, Autonomic Failure
Status: | Recruiting |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 40 - 80 |
Updated: | 10/21/2018 |
Start Date: | May 2016 |
End Date: | December 2020 |
Contact: | Jose Martinez |
Email: | martij34@nyumc.org |
Phase 2 Norepinephrine Transporter Blockade, Autonomic Failure
Atomoxetine, a selective norepinephrine transporter (NET) blocker, increases standing blood
pressure and improves neurogenic orthostatic hypotension (NOH)-related symptoms to a greater
extent than midodrine, the current standard of care. Atomoxetine could be a new therapeutic
alternative for the treatment of NOH in patients with autonomic failure, particularly those
with multiple system atrophy (MSA).
The proposed study consists of an open-label, dose-optimization phase followed by a
randomized, double-blind, placebo-controlled, 2x2 crossover phase.
pressure and improves neurogenic orthostatic hypotension (NOH)-related symptoms to a greater
extent than midodrine, the current standard of care. Atomoxetine could be a new therapeutic
alternative for the treatment of NOH in patients with autonomic failure, particularly those
with multiple system atrophy (MSA).
The proposed study consists of an open-label, dose-optimization phase followed by a
randomized, double-blind, placebo-controlled, 2x2 crossover phase.
Inclusion Criteria:
- Neurogenic Orthostatic Hypotension (defined by a reduction of ≥30 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
- Patients with narrow angle glaucoma
- Patients with or a history of pheochromocytoma
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Horacio Kaufman, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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