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Trial record 2 of 6 for:    "Pure Autonomic Failure" | "Norepinephrine"

Norepinephrine Transporter Blockade, Autonomic Failure

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ClinicalTrials.gov Identifier: NCT02796209
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE June 7, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date October 19, 2018
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Change from Baseline of Orthostatic Hypotension Questionnaire (OHQ) Score [ Time Frame: Days 0, 14, 28, 36, 50, and 64 ]
The OHQ is composed of 10 individual items: 6 items measure specific symptoms (the Orthostatic Hypotension Symptom Assessment [OHSA]), and 4 items measure the impact of those symptoms on a patient's daily activities (the Orthostatic Hypotension Daily Activity Scale [OHDAS])
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02796209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Norepinephrine Transporter Blockade, Autonomic Failure
Official Title  ICMJE Phase 2 Norepinephrine Transporter Blockade, Autonomic Failure
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Multiple System Atrophy (MSA)
Intervention  ICMJE
  • Drug: Atomexetine
    Upon completion of the 4-week treatment period (period 1), the investigator or research nurse will instruct the subject to discontinue the study medication for 1 week (wash-out period). After this period, the subject will complete the second 4-week treatment period (period 2).
  • Drug: Placebo
    Upon completion of the 4-week treatment period (period 1), the investigator or research nurse will instruct the subject to discontinue the study medication for 1 week (wash-out period). After this period, the subject will complete the second 4-week treatment period (period 2).
Study Arms  ICMJE
  • Experimental: Atomexetine
    Following the dose optimization phase, investigators will stratify the treatment assignment by Atomexetine dose (10mg or 19mg twice a day)
    Intervention: Drug: Atomexetine
  • Placebo Comparator: Placebo
    The placebo capsules will be of identical color, size, and approximate weight to provide an authentic blinded effect. The capsule contents will be a microcrystalline cellulose, NF (PH-105), which should not produce any adverse effects. It is a common pharmaceutical capsule filler used in the industry.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Martinez martij34@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796209
Other Study ID Numbers  ICMJE 16-00453
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Vanderbilt University Medical Center
Investigators  ICMJE
Principal Investigator: Horacio Kaufman, MD New York University Medical School
PRS Account NYU Langone Health
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP