A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Overview
- Phase
- Phase 3
- Intervention
- Droxidopa
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension
- Sponsor
- Chelsea Therapeutics
- Enrollment
- 61
- Locations
- 3
- Primary Endpoint
- Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years and older and ambulatory (defined as able to walk at least 10 meters);
- •Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency;
- •At the Baseline visit (Visit 2), patients must demonstrate:
- •a score of at least 4 or greater on the Orthostatic Hypotension Symptom Assessment (OHSA) Item #1;
- •a fall of at least 20 mmHg in their systolic blood pressure, within 3 minutes of standing;
- •Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care;
Exclusion Criteria
- •Score of 23 or lower on the mini-mental state examination (MMSE);
- •Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure;
- •Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2) and throughout the duration of the study;
- •Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse);
- •Women who are pregnant or breastfeeding;
- •Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner;
- •Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception;
- •Untreated closed angle glaucoma;
- •Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine HTN are allowed in this study) Any significant uncontrolled cardiac arrhythmia;
- •History of myocardial infarction, within the past 2 years;
Arms & Interventions
Droxidopa
Droxidopa 100 mg, 200 mg, 300 mg
Intervention: Droxidopa
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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.