Clinical Trial: A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy

Brief Summary: Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

Detailed Summary: This is a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study with a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose.
Sponsor: Chelsea Therapeutics

Current Primary Outcome: Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1) [ Time Frame: Change from Randomization to Week 1 ]

OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.


Original Primary Outcome: OHSA Item 1 [ Time Frame: Change from Randomization to Week 1 ]

Evaluate the duration of clinical benefits of droxidopa as demonstrated by the change in the Orthostatic Hypotension Symptom Assessment (OHSA) Item 1


Current Secondary Outcome:

Original Secondary Outcome:

  • Falls [ Time Frame: Change from Randomization to Week 12 ]
    Evaluate the clinical efficacy of droxidopa as demonstrated by a difference between placebo and droxidopa in patient reported falls from Randomization to the end of study visit at Week 12
  • Standing blood pressure [ Time Frame: Change from Randomization to Week 12 ]
    Evaluate the effect of droxidopa on standing blood pressure as demonstrated by a change from Randomization to the end of study visit at Week 12
  • Orthostatic Hypotension Questionnaire [ Time Frame: Change from Randomization to Week 12 ]
    Evaluate the clinical efficacy of droxidopa as demonstrated change in disease severity using the Orthostatic Hypotension Questionnaire (OHQ) composite score and individual item scores
  • Clinical Global Impression Scales [ Time Frame: Change from Randomization to Week 12 ]
    Evaluate the clinical efficacy of droxidopa as demonstrated by change in the clinician recorded and patient-recorded Clinical Global Impression-Severity (CGI-S) and the Clinical Global Impression-Improvement (CGI-I) scales from Randomization to the end of study visit at Week 12
  • Boston University Activity Measure for Post-Acute Care Basic Mobility [ Time Frame: Change from Randomization to Week 12 ]
    Evaluate the clinical efficacy of droxidopa as demonstrated by change in basic mobility using the Boston University Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form from Randomization to the end of study visit at Week 12


Information By: Chelsea Therapeutics

Dates:
Date Received: August 16, 2013
Date Started: November 2013
Date Completion:
Last Updated: December 4, 2015
Last Verified: December 2015