CLINICAL TRIALS PROFILE FOR NORTHERA

All Clinical Trials for NORTHERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01331122 ↗	Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease	Withdrawn	Chelsea Therapeutics	Phase 1/Phase 2	2012-04-01	Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients.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.
NCT01327066 ↗	Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose	Completed	Chelsea Therapeutics	Phase 1	2011-03-01	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.
NCT01176240 ↗	A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease	Completed	Chelsea Therapeutics	Phase 3	2010-06-01	This is a study to evaluate the effects of an investigational drug, Droxidopa, in participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's disease. Droxidopa is being studied to determine the effects on blood pressure changes upon standing up (orthostatic challenge). Symptoms and activity measurements, including patient reported falls, will be evaluated to determine the effectiveness of the study drug. Symptoms of NOH may include any of the following: - Dizziness, light-headedness, feeling faint or feeling like you may blackout - Problems with vision (blurring, seeing spots, tunnel vision, etc.) - Weakness - Fatigue - Trouble concentrating - Head & neck discomfort (the coat hanger syndrome) - Difficulty standing for a short time or a long time - Trouble walking for a short time or a long time The study duration is a maximum of approximately 14 weeks including up to 2 weeks for screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow approximately 211 randomized patients. An extension study is also available to continue treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored by Chelsea Therapeutics and is enrolling by invitation only.
NCT00633880 ↗	Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)	Completed	Chiltern International Inc.	Phase 3	2008-01-01	The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
NCT00633880 ↗	Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)	Completed	Chelsea Therapeutics	Phase 3	2008-01-01	The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
NCT00547911 ↗	Augmenting Effects of L-DOPS With Carbidopa and Entacapone	Terminated	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2	2007-10-01	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.

Clinical Trial Conditions for NORTHERA

Condition Name

Condition Name for NORTHERA
Intervention	Trials
Parkinson Disease	7
Multiple System Atrophy	3
Orthostatic Hypotension	2
Parkinson's Disease	2

Condition MeSH

Condition MeSH for NORTHERA
Intervention	Trials
Parkinson Disease	10
Hypotension, Orthostatic	7
Hypotension	7
Multiple System Atrophy	3

Clinical Trial Locations for NORTHERA

Trials by Country

+

−

Trials by Country for NORTHERA
Location	Trials
United States	92
Canada	4
Australia	3
New Zealand	2

Trials by US State

+

−

Trials by US State for NORTHERA
Location	Trials
Texas	5
New York	5
Arizona	5
Tennessee	4
Ohio	4

Clinical Trial Progress for NORTHERA

Clinical Trial Phase

Clinical Trial Phase for NORTHERA
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for NORTHERA
Clinical Trial Phase	Trials
Recruiting	5
Completed	5
Unknown status	3

Clinical Trial Sponsors for NORTHERA

Sponsor Name

Sponsor Name for NORTHERA
Sponsor	Trials
Chelsea Therapeutics	4
H. Lundbeck A/S	4
St. Joseph's Hospital and Medical Center, Phoenix	2

Sponsor Type

Sponsor Type for NORTHERA
Sponsor	Trials
Other	16
Industry	12
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for NORTHERA (Droxidopa)

Introduction to NORTHERA

NORTHERA, also known as droxidopa, is a medication approved by the FDA for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety Studies

The clinical trials for NORTHERA include several key studies that evaluated its efficacy and safety.

• Studies 301 and 302: These were short-term, placebo-controlled studies lasting 1 to 2 weeks. They showed a treatment effect of NORTHERA at Week 1, but no continued efficacy beyond 2 weeks[1][4].
• Study 306: This was an 8-week placebo-controlled study. While it showed initial symptom improvement, the treatment effects generally declined over time, and the primary efficacy variable lost statistical significance after Week 1[1][3].
• Long-Term, Open-Label Studies (Studies 303 and 304): These studies involved 422 patients treated with NORTHERA for approximately one year. Common adverse events included falls, urinary tract infections, headache, syncope, and dizziness[1].
• Study 16306A: A 12-week open-label and double-blind, placebo-controlled study assessed the sustained effects of NORTHERA. The most common adverse reaction was urinary tract infections[1].

Adverse Reactions

The most commonly observed adverse reactions in NORTHERA-treated patients during the placebo-controlled studies were headache, dizziness, nausea, and hypertension. Hypertension and nausea were the most common reasons for discontinuation[1][4].

Market Analysis

Current Market Size and Growth

The global orthostatic hypotension drugs market, which includes NORTHERA, was valued at approximately USD 678.57 million in 2023. This market is projected to grow to around USD 1437.68 million by 2032, with a Compound Annual Growth Rate (CAGR) of about 8.7% during the forecast period[2][5].

Market Segmentation

• By Drug Type: The market is segmented into midodrine, Northera (droxidopa), fludrocortisone, caffeine, and others. Currently, midodrine holds the largest market share, but Northera is expected to grow faster and emerge as the market leader by the end of the forecast period[2][5].
• By End User: The market is bifurcated into hospitals, ambulatory surgical centers (ASCs), clinics, and others. North America is the leading region in this market and is expected to maintain its dominant position[2].

Competitive Landscape

The global orthostatic hypotension drugs market is moderately fragmented with several major players, including:

• Amneal Pharmaceuticals Inc.
• H. Lundbeck AS
• Mylan N.V.
• Novartis AG
• Pfizer Inc.[2][5].

Projections and Future Outlook

Market Leadership

NORTHERA is anticipated to grow faster than other segments and emerge as the market leader by the end of the forecast period. This growth is driven by its ability to activate alpha 1 adrenergic receptors, which helps in ameliorating the symptoms of nOH[2][5].

Regional Dominance

North America is expected to continue its dominance in the orthostatic hypotension drugs market, driven by advanced healthcare infrastructure and higher adoption rates of new treatments[2].

Clinical and Market Impact

Despite the initial efficacy seen in short-term studies, the lack of sustained benefits beyond 2 weeks remains a challenge. However, the long-term open-label studies suggest that NORTHERA can be a viable option for managing symptoms of nOH over extended periods, albeit with careful monitoring of side effects.

"Northera can activate alpha 1 adrenergic receptors and have numerous physiological effects that may ameliorate the symptoms of nOH. This will contribute to the demand for Northera over the forecast period."[5]

Key Takeaways

• Clinical Trials: NORTHERA showed initial efficacy in short-term studies but lacked sustained benefits beyond 2 weeks. Long-term studies highlighted common adverse events.
• Market Size and Growth: The global orthostatic hypotension drugs market is expected to grow significantly, with NORTHERA projected to become the market leader.
• Market Segmentation: NORTHERA is part of a market segmented by drug type and end user, with North America leading in terms of region.
• Competitive Landscape: The market is moderately fragmented with several major pharmaceutical companies involved.
• Future Outlook: NORTHERA is expected to grow faster due to its physiological effects on nOH symptoms, despite the need for careful side effect management.

FAQs

What is NORTHERA used for?

NORTHERA (droxidopa) is used for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy.

What were the key findings from the clinical trials of NORTHERA?

Clinical trials showed initial symptom improvement at Week 1, but the treatment effects generally declined over time. Common adverse reactions included headache, dizziness, nausea, and hypertension.

How is the market for orthostatic hypotension drugs projected to grow?

The global orthostatic hypotension drugs market is expected to grow from USD 678.57 million in 2023 to around USD 1437.68 million by 2032, with a CAGR of about 8.7%.

Which segment is expected to lead the market in the future?

The Northera (droxidopa) segment is expected to grow faster and emerge as the market leader by the end of the forecast period.

What are the common adverse reactions associated with NORTHERA?

The most common adverse reactions include headache, dizziness, nausea, and hypertension, with hypertension and nausea being the most common reasons for discontinuation.

Who are the major players in the orthostatic hypotension drugs market?

Major players include Amneal Pharmaceuticals Inc., H. Lundbeck AS, Mylan N.V., Novartis AG, and Pfizer Inc.

Sources

1. Drugs.com: Northera: Package Insert / Prescribing Information.
2. Zion Market Research: Global Orthostatic Hypotension Drugs Market Size, Share, & Trends.
3. FDA: 203202Orig1s000 - accessdata.fda.gov.
4. Northera.com: NORTHERA Safety and Efficacy Information.
5. GlobeNewswire: Global Orthostatic Hypotension Drugs Markets to 2023 with Sales Data on Midodrine, Northera (Droxidopa), Fludrocortisone, and Other Drugs.