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Generated: February 16, 2019

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CLINICAL TRIALS PROFILE FOR NORTHERA

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Clinical Trials for Northera

Trial ID Title Status Sponsor Phase Summary
NCT00547911 Augmenting Effects of L-DOPS With Carbidopa and Entacapone Terminated National Institute of Neurological Disorders and Stroke (NINDS) Phase 1/Phase 2 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.
NCT00633880 Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) Completed Chiltern International Inc. Phase 3 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 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.
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 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.
NCT01327066 Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose Completed Chelsea Therapeutics Phase 1 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.
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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Northera

Condition Name

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

Condition MeSH for Northera
Intervention Trials
Parkinson Disease 10
Hypotension, Orthostatic 7
Hypotension 7
Atrophy 3
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Clinical Trial Locations for Northera

Trials by Country

Trials by Country for Northera
Location Trials
United States 75
Canada 4
Australia 3
New Zealand 2
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Trials by US State

Trials by US State for Northera
Location Trials
Arizona 5
New York 5
Texas 5
California 4
Tennessee 4
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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
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Clinical Trial Status

Clinical Trial Status for Northera
Clinical Trial Phase Trials
Recruiting 9
Completed 3
Withdrawn 2
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Clinical Trial Sponsors for Northera

Sponsor Name

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

Sponsor Type for Northera
Sponsor Trials
Other 13
Industry 12
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
McKinsey
Daiichi Sankyo
Express Scripts
US Army
Queensland Health
US Department of Justice
Fuji
Farmers Insurance

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