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Northera (Droxidopa) - Summary

 
 



WARNING: SUPINE HYPERTENSION

Monitor supine blood pressure prior to and during treatment and more frequently when increasing doses.  Elevating the head of the bed lessens the risk of supine hypertension, and blood pressure should be measured in this position.  If supine hypertension cannot be managed by elevation of the head of the bed, reduce or discontinue NORTHERA  [see Warnings and Precautions].

 

NORTHERA SUMMARY

NORTHERA capsules contain droxidopa, which is a synthetic amino acid precursor of norepinephrine, for oral administration.

NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure [Parkinson's disease (PD), multiple system atrophy, and pure autonomic failure], dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established.  The continued effectiveness of NORTHERA should be assessed periodically.


See all Northera indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Northera (Droxidopa)

Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia [Completed]
A correlation between increased norepinephrine concentration in the central nervous system (CNS) and a decrease in fibromyalgia pain has been suggested in clinical studies. Therefore, as a pro-drug of norepinephrine, droxidopa could potentially benefit fibromyalgia patients by reducing pain as a result of increasing CNS levels of norepinephrine. As this benefit is presumed to be a central effect, the addition of carbidopa, a peripheral DOPA decarboxylase (DDC) inhibitor, may favorably impact the drug's treatment profile. Carbidopa is utilized as a blocker of peripheral DDC, an enzyme required for the conversion of droxidopa into norepinephrine. Therefore, inhibition of peripheral DDC should result in a reduction of any side effects resulting from the peripheral production of norepinephrine, whilst allowing for increased central levels, and hence, increased centrally mediated benefits. The purpose of the study is the obtain information regarding the proper dosing, effectiveness and safety of droxidopa and combination droxidopa/carbidopa treatments in patients with fibromyalgia.

Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose [Completed]
The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin in healthy male and female subjects.

Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease [Withdrawn]
Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also called motor blocks, FoG is characterized by a sudden inability to move the lower extremities which usually lasts less than 10 seconds. The exact pathophysiology of FoG is poorly understood, but treatment with levodopa appears to improve FoG observed in the off-state. As Parkinson's patients progress in severity, FoG in the on-state can increase in frequency and appears to be resistant to dopaminergic therapies. There is additional evidence that norepinephrine as well as dopaminergic systems may be involved in FoG. Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or dizziness associated with Parkinson's Disease. This study is to further explore the safety and efficacy of droxidopa in this indication.

Augmenting Effects of L-DOPS With Carbidopa and Entacapone [Terminated]
An experimental drug called L-DOPS increases production in the body of a messenger chemical called norepinephrine. Cells in the brain that make norepinephrine are often gone in Parkinson disease. The exact consequences of this loss are unknown, but they may be related to symptoms such as fatigue, depression, or decreased attention that occur commonly in Parkinson disease. This study will explore effects of L-DOPS in conjunction with carbidopa and entacapone, which are drugs used to treat Parkinson disease. We wish to find out what the effects are of increasing norepinephrine production in the brain and whether carbidopa and entacapone augment those effects. Volunteers for this study must be at least 18 years of age and able to give consent to participate in the study. To participate in the study, volunteers must discontinue use of alcohol, tobacco, and certain herbal medicines or dietary supplements, and must also taper or discontinue certain kinds of medications that might interfere with the results of the study. Candidates will be screened with a medical history and physical exam. Participants will be admitted to the National Institutes of Health Clinical Center for two weeks of testing. The study will have three testing phases in a randomly chosen order for each participant:

- Single dose of L-DOPS

- Single dose of L-DOPS in conjunction with carbidopa

- Single dose of L-DOPS in conjunction with entacapone

Each phase will last two days, with a washout day between each phase in which no drugs will be given and no testing will be performed. In each phase, participants will undergo a series of tests and measurements, including blood pressure and electrocardiogram tests. Participants who are healthy volunteers will also have blood drawn and will undergo a lumbar puncture (also known as a spinal tap) to obtain spinal fluid for chemical tests.

A Dose Titration of Droxidopa in Patients With Spinal Cord Injury [Completed]
The investigators seek to determine the efficacy, duration of action and safety of escalating dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and catecholamines during upright seated posture. Primary Question: 1. What is the lowest dose of droxidopa that increases seated SBP to 1155 mmHg in men and 1055 mmHg in women?

- When does the defined increase in SBP occur after oral ingestion of droxidopa?

- How long does this dose of droxidopa sustain SBP at these levels?

- What are the vital signs and the subjective symptomology following droxidopa

administration? Secondary Question: 1. What is the MFV response to droxidopa administration in hypotensive individuals with SCI?

- Does an increase in SBP correspond to an increase in MCA MFV?

Tertiary Question: 1. What is the vasoactive hormone and catecholamine response to droxidopa administration in hypotensive individuals with SCI?

- Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive

individuals with SCI?

more trials >>


Page last updated: 2014-08-01

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