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SLUHN 2017-19

RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Leah Bryant, LPN

  • Synopsis: You are being asked to participate in this study because you have a condition known as symptomatic neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure [Parkinson’s Disease (PD), Multiple System Atrophy (MSA) or Pure Autonomic Failure (PAF)], or Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) deficiency. However, your ability to participate in the study will depend on the results of the screening procedures described below and other criteria.

    These conditions involve problems with the parts of your nervous system that control your blood pressure, especially when you are standing. Normally, when a person stands up, his or her nervous system reacts so that the blood pressure does not change. When people who have NOH stand up, their blood pressure falls (decreases). This drop in blood pressure can cause a number of different symptoms, especially dizziness or light-headedness, feeling like you are going to faint, or even fainting and these symptoms can make it difficult to stand for a long time without having to sit or lay down.

    The purpose of this research study is to evaluate the durability of the effectiveness and safety of a study drug called droxidopa (also known by the trade name NORTHERA®) in people with symptomatic NOH. Droxidopa is a drug that is changed in the body to a chemical called norepinephrine. Norepinephrine is a chemical in your body that is used by your nervous system to signal nerves that control blood pressure.

    Droxidopa (NORTHERA®) has been approved in the United States (US) for the treatment of orthostatic dizziness, light-headedness or the “feeling that you are about to black out” in patients with a clinical diagnosis of symptomatic NOH due to PD, MSA, PAF, NDAN, or DBH deficiency.

    The study drug that you will take if you are in this study is a capsule that contains either droxidopa or placebo (an identical-looking pill that does not contain any active drug; a placebo is sometimes called a “sugar pill”). The reason for having people take placebo in this study is to see if taking droxidopa is better than taking placebo. Be aware that this form refers to both droxidopa and placebo as “study drug”. The use of droxidopa in this study is considered investigational.

    Because this is a research study, droxidopa will be given to you only during this study and not after the study is over. 

    • 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)

    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
    • 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, within the past 2 years
    • Current unstable angina
    • Congestive heart failure (NYHA Class 3 or 4)
    • Diabetic autonomic neuropathy

    Additional protocol defined inclusion and exclusion criteria do apply