a clinical study of patients with symptomatic noh to assess sustained effects of droxidopa therapy

Conditions: Symptomatic Neurogenic Orthostatic Hypotension; Parkinson's Disease; Multiple Systems Atrophy; Pure Autonomic Failure; Dopamine Beta Hydroxylase Deficiency

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

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.

Eligibility criteria:
inclusion criteria: * 1. 18 years and older and ambulatory (defined as able to walk at least 10 meters); 2. clinical diagnosis of symptomatic orthostatic hypotension associated with primary autonomic failure (pd, msa and paf), dopamine beta hydroxylase deficiency; 3. at the baseline visit (visit 2), patients must demonstrate: 1. a score of at least 4 or greater on the orthostatic hypotension symptom assessment (ohsa) item #1; 2. a fall of at least 20 mmhg in their systolic blood pressure, within 3 minutes of standing; 4. 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: * 1. score of 23 or lower on the mini-mental state examination (mmse); 2. concomitant use of vasoconstricting agents for the purpose of increasing blood pressure; 1. 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; 3. known or suspected alcohol or substance abuse within the past 12 months (dsm-iv definition of alcohol or substance abuse); 4. women who are pregnant or breastfeeding; 5. women of child bearing potential (wocp) who are not using at least one method of contraception with their partner; 6. male patients who are sexually active with a woman of child bearing potential (wocp) and not using at least one method of contraception; 7. untreated closed angle glaucoma; 8. 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; 9. history of myocardial infarction, within the past 2 years; 10. current unstable angina; 11. congestive heart failure (nyha class 3 or 4); 12. 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; 13. gastrointestinal condition that may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass); 14. any major surgical procedure within 30 days prior to the baseline visit (visit 2); 15. previously treated with droxidopa within 30 days prior to the baseline visit (visit 2); 16. currently receiving any other investigational drug or have received an investigational drug within 30 days prior to the baseline visit (visit 2); 17. 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; 18. 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.

Keywords: noh oh pd msa paf dbh