Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    482
  • sponsor
    Lundbeck Northera Ltd.
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Updated on 17 December 2020
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Investigator
Sean Montague
Primary Contact
Georgetown University (7.9 mi away) Contact
+126 other location

Summary

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)

Description

This is a multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention study with a duration of up to 36 weeks, consisting of 5 periods:

Screening Period: up to 4 weeks duration; Open-Label Titration Period (Titration Period): up to 4 weeks duration; Open-Label Treatment Period (Open-Label Period): 12 weeks duration; Double-Blind Treatment Period (Double-Blind Period): 12 weeks duration; Safety Follow-Up Period: 4 weeks duration

Details
Treatment Placebo capsules, Droxidopa capsules
Clinical Study IdentifierNCT02586623
SponsorLundbeck Northera Ltd.
Last Modified on17 December 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Symptomatic Neurogenic Orthostatic Hypotension?
Do you have any of these conditions: Do you have Symptomatic Neurogenic Orthostatic Hypotension??
Do you have any of these conditions: Do you have Symptomatic Neurogenic Orthostatic Hypotension??
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

Exclusion Criteria

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
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