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Droxidopa

Generic Name
Droxidopa
Brand Names
Northera
Drug Type
Small Molecule
Chemical Formula
C9H11NO5
CAS Number
23651-95-8
Unique Ingredient Identifier
J7A92W69L7
Background

Droxidopa is a precursor of noradrenaline that is used in the treatment of Parkinsonism. It is approved for use in Japan and is currently in trials in the U.S. The racaemic form (dl-threo-3,4-dihydroxyphenylserine) has also been used, and has been investigated in the treatment of orthostatic hypotension. There is a deficit of noradrenaline as well as of dopamine in Parkinson's disease and it has been proposed that this underlies the sudden transient freezing seen usually in advanced disease.

Though L-DOPS has been used in Japan and Southeast Asia already for some time, it is also currently in clinical trials at the phase III point in the United States (U.S.), Canada, Australia, and throughout Europe. Provided L-DOPS successfully completes clinical trials, it could be approved for the treatment of neurogenic orthostatic hypotension (NOH) as early as 2011. Additionally, phase II clinical trials for intradialytic hypotension are also underway. Chelsea Therapeutics obtained orphan drug status (ODS) for L-DOPS in the U.S. for NOH, and that of which associated with Parkinson's disease , pure autonomic failure, and multiple system atrophy, and is the pharmaceutical company developing it in that country.

Indication

For treatment of neurogenic orthostatic hypotension (NOH) associated with various disorders including Multiple System Atrophy, Familial Amyloid Polyneuropathy, hemodialysis induced hypotension and Parkinson's Disease. Also investigated for use/treatment in neurologic disorders, nephropathy, blood (blood forming organ disorders, unspecified), and dizzy/fainting spells.

Associated Conditions
Symptomatic Neurogenic Orthostatic Hypotension (NOH)
Associated Therapies
-

Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease

Phase 2
Conditions
Parkinson Disease
Interventions
Drug: Placebo
Drug: L-DOPS
First Posted Date
2016-06-24
Last Posted Date
2019-02-15
Lead Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Target Recruit Count
20
Registration Number
NCT02812147
Locations
🇺🇸

Barrow Neurological Institute/St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease

Phase 2
Conditions
Parkinson's Disease
Freezing of Gait
Cognitive Ability, General
Interventions
Drug: Droxidopa
Drug: sugar pill
First Posted Date
2014-02-19
Last Posted Date
2016-11-03
Lead Sponsor
Henry Ford Health System
Target Recruit Count
20
Registration Number
NCT02066571
Locations
🇺🇸

Henry Ford Hospital, West Bloomfield, West Bloomfield, Michigan, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

Phase 3
Terminated
Conditions
Multiple Systems Atrophy
Pure Autonomic Failure
Parkinson's Disease
Symptomatic Neurogenic Orthostatic Hypotension
Dopamine Beta Hydroxylase Deficiency
Interventions
Drug: Placebo
Drug: Droxidopa
First Posted Date
2013-08-22
Last Posted Date
2016-01-08
Lead Sponsor
Chelsea Therapeutics
Target Recruit Count
61
Registration Number
NCT01927055
Locations
🇺🇸

Information on additional locations involved in this clinical trial contact Chelsea Therapeutics, Charlotte, North Carolina, United States

🇺🇸

NYU Langone Medical Center, New York, New York, United States

🇺🇸

Wisconsin Institute for Neurology and Sleep Disorders, Milwaukee, Wisconsin, United States

Phase 3 Study to Evaluate the Efficacy and Safety of Droxidopa on Orthostatic Hypotension Treatment in Hemodialysis Patients

Phase 3
Terminated
Conditions
Orthostatic Hypotension
Interventions
Drug: Placebo
Drug: Droxidopa
First Posted Date
2012-06-05
Last Posted Date
2013-03-13
Lead Sponsor
TSH Biopharm Corporation Limited
Target Recruit Count
25
Registration Number
NCT01612078
Locations
🇨🇳

Taipei Medical University Hospital, Taipei, Taiwan

A Multi-Center, Open-Label Study

Phase 1
Withdrawn
Conditions
Renal Disease
End Stage Renal Disease
Interventions
First Posted Date
2011-11-09
Last Posted Date
2013-03-29
Lead Sponsor
Chelsea Therapeutics
Registration Number
NCT01468259
Locations
🇺🇸

NOCCR, Knoxville, Tennessee, United States

Droxidopa / Pyridostigmine in Orthostatic Hypotension

Phase 2
Suspended
Conditions
Orthostatic Hypotension
Interventions
First Posted Date
2011-06-10
Last Posted Date
2024-06-06
Lead Sponsor
Mayo Clinic
Target Recruit Count
30
Registration Number
NCT01370512
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

A Dose Titration of Droxidopa in Patients With Spinal Cord Injury

Phase 1
Completed
Conditions
Hypotension
Spinal Cord Injury
Interventions
First Posted Date
2011-05-16
Last Posted Date
2013-07-30
Lead Sponsor
Bronx VA Medical Center
Target Recruit Count
11
Registration Number
NCT01354158
Locations
🇺🇸

James J. Peters VA Medical Center, Bronx, New York, United States

Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease

Phase 1
Withdrawn
Conditions
Gait Disorders, Neurologic
Interventions
First Posted Date
2011-04-07
Last Posted Date
2013-03-29
Lead Sponsor
Chelsea Therapeutics
Registration Number
NCT01331122
Locations
🇨🇦

University of Alberta, Movement Disorders Clinic Glenrose Rehabilitation Hospital, Edmonton, Alberta, Canada

🇺🇸

Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States

Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose

Phase 1
Completed
Conditions
QTc Interval
Interventions
First Posted Date
2011-04-01
Last Posted Date
2012-03-07
Lead Sponsor
Chelsea Therapeutics
Target Recruit Count
52
Registration Number
NCT01327066
Locations
🇺🇸

PPD Phase I Clinic, Austin, Texas, United States

Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia

Phase 2
Completed
Conditions
Fibromyalgia
Interventions
Drug: Droxidopa/carbidopa
Drug: Placebo
Drug: Carbidopa
Drug: Droxidopa
First Posted Date
2011-03-25
Last Posted Date
2024-02-14
Lead Sponsor
Chelsea Therapeutics
Target Recruit Count
122
Registration Number
NCT01323374
Locations
🇬🇧

MAC UK Neuroscience, Manchester, United Kingdom

🇬🇧

Academic Dept of Rheumatology, Kings College London, London, United Kingdom

🇬🇧

Rheumatology Department, Poole Hospital NHS Trust, Poole, United Kingdom

and more 3 locations
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