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

Stopped early · Phase 3 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT01927055

Run by

Chelsea Therapeutics

People needed

61

Starts

2013-11-01

Expected to finish

2015-02-01

Last updated by the study team

2016-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. 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;

You may not qualify if…

• 1. 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.

Where it is running

• NYU Langone Medical Center — New York, New York, United States
• Information on additional locations involved in this clinical trial contact Chelsea Therapeutics — Charlotte, North Carolina, United States
• Wisconsin Institute for Neurology and Sleep Disorders — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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