Northera

Parkinson's Disease, Dopamine-beta-monooxygenase, Symptomatic Neurogenic Orthostatic Hypotension (NOH) + 3 more

Treatment

9 FDA approvals

20 Active Studies for Northera

What is Northera

Droxidopa

The Generic name of this drug

Treatment Summary

Droxidopa is a medication used to treat Parkinsonism. It is approved for use in Japan and is being tested in the United States, Canada, Australia, and Europe. It works by increasing the amount of noradrenaline in the body and is used to treat orthostatic hypotension. If the clinical trials are successful, Droxidopa could be approved for the treatment of neurogenic orthostatic hypotension in 2011. It has also been granted orphan drug status (ODS) to treat Parkinson's disease and other related conditions.

Northera

is the brand name

image of different drug pills on a surface

Northera Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Northera

Droxidopa

2014

57

Approved as Treatment by the FDA

Droxidopa, also called Northera, is approved by the FDA for 9 uses like Progressive autonomic failure and Dopamine-beta-monooxygenase .

Progressive autonomic failure

Dopamine-beta-monooxygenase

Parkinson's Disease (PD)

Multiple System Atrophy (MSA)

Symptomatic Neurogenic Orthostatic Hypotension (NOH)

Non-Diabetic Autonomic Neuropathy

Multiple System Atrophy

Shy-Drager Syndrome

Parkinson's Disease

Effectiveness

How Northera Affects Patients

Droxidopa is a medication taken by mouth that helps to increase the amount of norepinephrine in the body for those with Neurogenic Orthostatic Hypotension (NOH). This can help to improve blood pressure when standing and reduce symptoms such as feeling lightheaded, dizziness, blurry vision, and fainting. It does this by increasing the heart rate and causing an increase in blood pressure.

How Northera works in the body

Droxidopa enters the brain, where it is converted into a molecule called norepinephrine. Norepinephrine works on different types of receptors in the body to constrict blood vessels and stimulate the heart. It also works to widen arteries.

When to interrupt dosage

The proposed dose of Northera is contingent upon the diagnosed condition, including Shy-Drager Syndrome, Multiple System Atrophy (MSA) and Non-Diabetic Autonomic Neuropathy. The magnitude of dosage is contingent upon the delivery approach laid out in the table beneath.

Condition

Dosage

Administration

Parkinson's Disease

100.0 mg, , 200.0 mg, 300.0 mg, 0.3 mg, 0.2 mg, 0.1 mg

, Oral, Capsule, Capsule - Oral

Dopamine-beta-monooxygenase

100.0 mg, , 200.0 mg, 300.0 mg, 0.3 mg, 0.2 mg, 0.1 mg

, Oral, Capsule, Capsule - Oral

Symptomatic Neurogenic Orthostatic Hypotension (NOH)

100.0 mg, , 200.0 mg, 300.0 mg, 0.3 mg, 0.2 mg, 0.1 mg

, Oral, Capsule, Capsule - Oral

Multiple System Atrophy

100.0 mg, , 200.0 mg, 300.0 mg, 0.3 mg, 0.2 mg, 0.1 mg

, Oral, Capsule, Capsule - Oral

Non-Diabetic Autonomic Neuropathy

100.0 mg, , 200.0 mg, 300.0 mg, 0.3 mg, 0.2 mg, 0.1 mg

, Oral, Capsule, Capsule - Oral

Shy-Drager Syndrome

100.0 mg, , 200.0 mg, 300.0 mg, 0.3 mg, 0.2 mg, 0.1 mg

, Oral, Capsule, Capsule - Oral

Warnings

There are 20 known major drug interactions with Northera.

Common Northera Drug Interactions

Drug Name

Risk Level

Description

2,5-Dimethoxy-4-ethylamphetamine

Major

The therapeutic efficacy of 2,5-Dimethoxy-4-ethylamphetamine can be increased when used in combination with Droxidopa.

2,5-Dimethoxy-4-ethylthioamphetamine

Major

The therapeutic efficacy of 2,5-Dimethoxy-4-ethylthioamphetamine can be increased when used in combination with Droxidopa.

4-Bromo-2,5-dimethoxyamphetamine

Major

The therapeutic efficacy of 4-Bromo-2,5-dimethoxyamphetamine can be increased when used in combination with Droxidopa.

Acebutolol

Major

The therapeutic efficacy of Acebutolol can be increased when used in combination with Droxidopa.

Amphetamine/Dextroamphetamine

Major

The therapeutic efficacy of Amphetamine can be increased when used in combination with Droxidopa.

Northera Toxicity & Overdose Risk

Droxidopa exhibits low toxicity, with the highest dose of the drug causing no deaths in mice, rats, dogs, and monkeys. A small percentage of patients (0.78%) may experience side effects such as nausea, headaches, high blood pressure, hallucinations, and loss of appetite.

image of a doctor in a lab doing drug, clinical research

Northera Novel Uses: Which Conditions Have a Clinical Trial Featuring Northera?

Currently, 46 clinical trials are being conducted to investigate the potential of Northera for alleviating Dopamine-beta-monooxygenase Deficiency, Parkinson's Disease and Non-Diabetic Autonomic Neuropathy.

Condition

Clinical Trials

Trial Phases

Dopamine-beta-monooxygenase

0 Actively Recruiting

Symptomatic Neurogenic Orthostatic Hypotension (NOH)

1 Actively Recruiting

Phase 3

Non-Diabetic Autonomic Neuropathy

0 Actively Recruiting

Shy-Drager Syndrome

4 Actively Recruiting

Not Applicable, Phase 3

Parkinson's Disease

39 Actively Recruiting

Not Applicable, Phase 1, Phase 4, Phase 2, Phase 3, Early Phase 1

Multiple System Atrophy

2 Actively Recruiting

Not Applicable, Phase 3

Northera Reviews: What are patients saying about Northera?

5

Patient Review

9/11/2016

Northera for Feeling Dizzy Upon Standing from Blood Pressure Drop

I was struggling with my adrenal gland after chemotherapy a few years ago, but this treatment completely changed things for me. I've been on Northera for over two weeks and I feel incredible. Not only do I have more energy than ever before, but my orthostatic blood pressure is now normal!

4

Patient Review

6/16/2017

Northera for Feeling Dizzy Upon Standing from Blood Pressure Drop

I've been using Northera for 18 months now, and it's been a huge help. Prior to taking this medication, I was passing out 3-4 times a day. But since starting on Northera, that problem has completely stopped. However, several months ago my mild headaches turned into daily migraines that come with vomiting. So now I'm in the process of weaning myself off the medication. I just hope that the passing out doesn't come back!

4

Patient Review

3/14/2015

Northera for Feeling Dizzy Upon Standing from Blood Pressure Drop

The stiffness in my muscles is really debilitating. I feel achy and sore all the time. It's hard to do simple things like get up off the floor because it hurts so much.

3

Patient Review

5/15/2015

Northera for Feeling Dizzy Upon Standing from Blood Pressure Drop

I had to cut down the dosage because the highest amount gave me terrible headaches. It also made me feel nauseated and really tired. I'm considering going back to my previous medication because it at least helped with my energy levels, even though it didn't completely fix the problem.

2.7

Patient Review

2/9/2015

Northera for Feeling Dizzy Upon Standing from Blood Pressure Drop

So far, Northera has given me headaches and nausea. I'm supposed to be increasing my dosage each week until I reach 600 mg 3x/day, but the side effects are really bothering me. Hopefully they'll go away soon.

1

Patient Review

3/24/2017

Northera for Feeling Dizzy Upon Standing from Blood Pressure Drop

I'm an 18 year old female who was taking this for treatment of NCS, and very low blood pressure. I had been hoping this would help me. However, I could only take it for 2 days because the side effects were so awful. They included extreme headaches, chest discomfort, a doubled heart rate, and feeling even more exhausted than before. This unfortunately did not help at all.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about northera

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the side effects of Northera?

"Those with POTS may experience headaches, dizziness, nausea, high blood pressure, fatigue, falls, urinary tract infections, and fainting."

Answered by AI

What drug class is Northera?

"Northera is a medicine that belongs to a group of drugs called alpha/beta agonists."

Answered by AI

Does Northera increase blood pressure?

"NORTHERA may cause high blood pressure when lying down, which could lead to strokes, heart attacks, and death. Taking your late afternoon dose of NORTHERA at least 3 hours before going to bed can help reduce this risk of supine hypertension."

Answered by AI

What is Northera prescribed for?

"This text is about a medication called Northera that is used to reduce dizziness and lightheadedness in adults who have symptomatic neurogenic orthostatic hypotension (nOH) and who have Parkinson's disease, multiple system atrophy, pure autonomic failure, or dopamine beta-hydroxylase deficiency."

Answered by AI

Clinical Trials for Northera

Image of Invicro (dba Perceptive) in New Haven, United States.

[18F]MK-0947 for Parkinson's Disease

18 - 80
All Sexes
New Haven, CT

This clinical study is being conducted to learn more about a new imaging drug called \[18F\]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders. The main goal of this study is to find out if \[18F\]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time. Who can join? Adults who have PD or who are healthy may be able to take part. Participants will have screening tests to make sure they qualify. What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants. Why is this important? There is currently no cure for PD, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PD and similar conditions in the future.

Phase < 1
Recruiting

Invicro (dba Perceptive)

Merck Sharp & Dohme LLC

Image of St. Francis Hospital The Heart Center in Roslyn, United States.

Angioplasty or Stenting for Postural Hypotension

18+
All Sexes
Roslyn, NY

Orthostatic hypotension (OH) and orthostatic intolerance (OI) are common conditions where blood pressure drops when standing up, causing dizziness, fainting, or fatigue. These affect up to 30% of adults over 65 and raise risks for heart disease, stroke, kidney problems, and more. Current medications often don't fully help and can cause side effects like high blood pressure when lying down. The STANDUP study tests a new approach: using a minimally invasive procedure to open narrowed veins above the heart (supracardiac veins) that may block blood flow back to the heart. We believe fixing these blockages could improve blood pressure control and reduce symptoms. This is a 2-year study enrolling 100 adults (age 18+) with OH or OI that hasn't improved with standard treatments or is worsened by lying-down high blood pressure. What happens in the study? Participants get imaging (like X-rays and ultrasound) to check for vein narrowing. If needed, doctors use a thin tube (catheter) through a small skin puncture to inflate a tiny balloon (angioplasty) or place a small mesh tube (stent) to widen the veins. The procedure takes a few hours under local anesthesia, with monitoring for safety. Follow-up visits check symptoms, blood pressure, and quality of life at 2-4 weeks, 3 months, 6 months, 1 year, and 2 years. Who can join? Adults 18+ with diagnosed OH/OI not helped by meds. Must give informed consent. Not eligible if: Pregnant, breastfeeding, actively infected, or unable to take blood thinners. Possible benefits: Better standing tolerance, fewer symptoms, improved daily life, less need for meds, and new knowledge on vein issues in OH/OI. Risks: Rare but include bleeding, infection, stroke, vein clots, stent issues, radiation from imaging, or temporary symptom worsening. We'll monitor closely and report any problems. This single-arm trial (no placebo group) will compare before-and-after results to see if the procedure helps. No study drug costs; covered by insurance or clinic. Led by Dr. Karthikeyan Arcot at St. Francis Hospital, Roslyn, NY. Contact for details.

Recruiting
Has No Placebo

St. Francis Hospital The Heart Center

Karthikeyan M Arcot, MD

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Image of Centre for Brain and Mind, Western University in London, Canada.

Cognitive Cueing + Video Intervention for Parkinson's Disease

40 - 99
All Sexes
London, Canada

The goal of this clinical trial is to learn if cognitive cueing (eg., prompting individuals to think about taking big-long steps while walking), either as a stand- alone intervention or combined with a personalized gait training video, can improve gait (walking), mobility, and balance confidence for individuals with Parkinson's Disease. The main questions it aims to answer are: 1. Does focusing on cognitive cues while walking improve gait, mobility, and balance confidence for individuals with Parkinson's Disease? 2. Does incorporating a personalized gait training video alongside cognitive cueing lead to amplified improvements in gait, mobility, and balance confidence for individuals with Parkinson's Disease? Researchers will compare how gait, mobility, balance confidence and quality of life change over time for participants when they practice walking with and without a cognitive cue alone, and when they practice with using a personalized gait training video. The researchers are also interested in how participation in this trial will affect quality of life and conscious attention to gait. Participants will * Complete walking trials on an instrumented mat that records data on their walking ability. These trials will be undertaken without a cognitive cue and while participants mentally rehearse a series of 3 cognitive cues (Take big long steps; Walk heel-toe; Stand up straight). * Be informed about which of the 3 cues best improved their walking and will receive a personalized gait training video for at home practice. * Complete online surveys that ask questions about their Parkinson's Disease, mobility, balance confidence quality of life and conscious attention to gait. * Visit the research facility 3 to 4 times during the study to have their gait (walking), mobility, balance confidence, quality of life and conscious attention to gait assessed and reassessed. * Practice both with and without their personalized video at home and keep a diary to record their practice sessions * Participate in a brief interview to discuss their experiences with the training and their perceptions of the effectiveness of cognitive cues and video-recorded feedback

Waitlist Available
Has No Placebo

Centre for Brain and Mind, Western University

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Image of Austin Clinic PPD in Austin, United States.

LY3962681 for Parkinson's Disease

30 - 80
All Sexes
Austin, TX

The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.

Phase 1
Recruiting

Austin Clinic PPD

Travis Lewis

Prevail Therapeutics

Image of Edward Hines Jr. VA Hospital, Hines, IL in Hines, United States.

Non-Invasive Vagal Nerve Stimulation for Parkinson's Disease

50 - 88
All Sexes
Hines, IL

More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.

Waitlist Available
Has No Placebo

Edward Hines Jr. VA Hospital, Hines, IL

Sandra L. Kletzel, PhD BA

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