Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

  • End date
    Sep 30, 2022
  • participants needed
  • sponsor
    Lundbeck Northera Ltd.
Updated on 27 January 2021


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)


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

Condition Symptomatic Neurogenic Orthostatic Hypotension
Treatment Placebo capsules, Droxidopa capsules
Clinical Study IdentifierNCT02586623
SponsorLundbeck Northera Ltd.
Last Modified on27 January 2021


Yes No Not Sure

Inclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note