Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

Completed · Phase 4 · Has a placebo group

Conditions studied: Symptomatic Neurogenic Orthostatic Hypotension

In brief

To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)

Key facts

Study ID

NCT02586623

Run by

H. Lundbeck A/S

People needed

453

Starts

2016-02-11

Expected to finish

2022-09-09

Last updated by the study team

2023-08-23

Who can join

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

You may qualify if…

• 18 years or older and able to stand (with or without limited assistance)
• Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency
• Score of at least 4 or greater on Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 (measured at Screening [Visit 1] and the first Titration Visit [Visit 2a] prior to dosing)
• A documented drop of at least 20 millimeters of mercury (mmHg) in SBP, within 3 minutes of standing. This can either be documented in the patient history or assessed during Screening prior to the first Titration Visit (Visit 2a)
• 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
• Additional inclusion criteria for patients taking prescribed droxidopa prior to study entry:
• Patients who are taking prescribed droxidopa therapy are eligible to participate in the study if they meet the other inclusion criteria and also have been on a stable dose of prescribed droxidopa for at least 2 weeks prior to the Screening Visit (Visit 1). In addition, they must meet either of the following at the Screening Visit (Visit 1):
• The patient's Visit 1 OHSA Item #1 score is ≥ 7 AND the prescribed dose is ≤ 300 mg three times daily (TID); OR
• The patient's Visit 1 OHSA Item #1 score is ≤6 AND worsens by ≥ 2 units when retested after washing out of droxidopa for at least 3 days

You may not qualify if…

• In the investigator's opinion, the patient is not able to understand or cooperate with study procedures
• Known or suspected alcohol or substance use disorder within the past 12 months (DSM-5 criteria)
• Women who are pregnant or breastfeeding
• Women of childbearing potential (WOCP) who are not using at least one method of contraception with their partner
• Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic. Sustained is defined as the average of 3 observations each at least 10 minutes apart with the patient having been supine and at rest for at least 5 minutes prior to each measurement.
• Untreated closed angle glaucoma
• Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine hypertension are allowed in this study)
• Any significant uncontrolled cardiac arrhythmia
• History of myocardial infarction or stroke, within the past 2 years
• Current unstable angina
• Congestive heart failure (NYHA Class 3 or 4)
• Diabetic autonomic neuropathy
• 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
• Any major surgical procedure within the past 30 days
• Currently receiving any investigational drug or have received an investigational drug within the past 28 days
• Additional protocol defined exclusion criteria do apply

Where it is running

• 21st Century Neurology — Phoenix, Arizona, United States
• Movement Disorders Center of Arizona — Scottsdale, Arizona, United States
• Center For Neurosciences — Tucson, Arizona, United States
• Movement Disorder Clinic - The University of Arizona — Tucson, Arizona, United States
• University of Arizona Health Sciences Center, Department Of Neurology — Tucson, Arizona, United States
• Arkansas Cardiology Clinic — Little Rock, Arkansas, United States
• East Bay Physicians Medical Group — Berkeley, California, United States
• Sutter East Bay Medical Foundation — Berkeley, California, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Behavioral Research Specialists, LLC — Glendale, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• University Of Southern California — Los Angeles, California, United States
• Parkinson's Institute and Clinical Center — Mountain View, California, United States
• Diverse Research Solutions, LLC — Oxnard, California, United States
• Focilmed — Oxnard, California, United States
• Parkinsons Disease & Movement Disorder of Silicon Valley — Palo Alto, California, United States
• Neurosearch, Inc. - Pasedena — Pasadena, California, United States
• Neurosearch, Inc. - Ventura — Pasadena, California, United States
• SC3 Research Group — Pasadena, California, United States
• Neurosearch, Inc. - Reseda — Reseda, California, United States
• Radiological Associates of Sacramento — Sacramento, California, United States
• Sutter Neuroscience — Sacramento, California, United States
• The Parkinson's Institute and Clinical Center — Sunnyvale, California, United States
• Neurosearch Inc. - Torrance — Torrance, California, United States
• MDFirst Research - Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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