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