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

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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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;

  • 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;
  • Current unstable angina;
  • Congestive heart failure (NYHA Class 3 or 4);
  • History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ;
  • Gastrointestinal condition that may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass);
  • Any major surgical procedure within 30 days prior to the Baseline visit (Visit 2);
  • Previously treated with droxidopa within 30 days prior to the Baseline visit (Visit 2);
  • Currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the Baseline visit (Visit 2);
  • Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study;
  • The Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.

Sites

  • Wisconsin

    • Wisconsin Institute for Neurology and Sleep Disorders, Milwaukee, Wisconsin, 53233
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