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Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) (NOH304)

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ClinicalTrials.gov Identifier: NCT01132326
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : April 21, 2014
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Chelsea Therapeutics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Autonomic Failure
Dopamine Beta Hydroxylase Deficiency
Non-Diabetic Neuropathy
Neurogenic Orthostatic Hypotension
Intervention Drug: Droxidopa
Enrollment 350

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Droxidopa
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Open-Label Droxidopa

Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

Period Title: Overall Study
Started 350
Completed 132
Not Completed 218
Reason Not Completed
Lack of Efficacy             25
Adverse Event             37
Protocol Violation             1
Lost to Follow-up             16
Withdrawal by Subject             40
Physician Decision             10
Study Termination             80
Declining Health             1
Pregnancy             1
Caregiver Withdrew Consent             1
Death             5
Subject Unable to Come To Visits             1
Arm/Group Title Droxidopa
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Open-Label Droxidopa

Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

Overall Number of Baseline Participants 350
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 350 participants
65.9  (15.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 350 participants
Female
136
  38.9%
Male
214
  61.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 350 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   1.1%
White
344
  98.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 350 participants
United States 263
Europe 87
Primary Clinical Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 350 participants
Parkinson's Disease 232
Multiple System Atrophy 33
Pure Autonomic Failure 68
Dopamine Beta-Hydroxylase Deficiency 0
Non-Diabetic Autonomic Neuropathy 8
Other 7
Missing 2
1.Primary Outcome
Title Patients With Treatment-emergent Adverse Events
Hide Description Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Droxidopa
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Open-Label Droxidopa

Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

Overall Number of Participants Analyzed 350
Measure Type: Number
Unit of Measure: participants
263
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Droxidopa
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Open-Label Droxidopa

Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months

All-Cause Mortality
Droxidopa
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Droxidopa
Affected / at Risk (%) # Events
Total   83/350 (23.71%)    
Blood and lymphatic system disorders   
Pancytopenia  1/350 (0.29%)  1
Cardiac disorders   
Atrial fibrillation  2/350 (0.57%)  2
Cardio-respiratory arrest  2/350 (0.57%)  2
Myocardial infarction  2/350 (0.57%)  2
Atrial flutter  1/350 (0.29%)  1
Bradycardia  1/350 (0.29%)  1
Cardiac arrest  1/350 (0.29%)  1
Cardiac failure congestive  1/350 (0.29%)  1
Supra-ventricular tachycardia  1/350 (0.29%)  1
Endocrine disorders   
Hyperparathyroidism primary  1/350 (0.29%)  1
Gastrointestinal disorders   
Constipation  2/350 (0.57%)  2
Diarrhea  2/350 (0.57%)  2
Colitis ischemia  1/350 (0.29%)  1
Dysphagia  1/350 (0.29%)  1
Inguinal hernia  1/350 (0.29%)  2
Lower gastrointestinal hemorrhage  1/350 (0.29%)  1
General disorders   
Asthenia  3/350 (0.86%)  3
Non-cardiac chest pain  2/350 (0.57%)  2
Chest discomfort  1/350 (0.29%)  1
Chest pain  1/350 (0.29%)  1
Gait disturbance  1/350 (0.29%)  1
Hyperthermia  1/350 (0.29%)  1
Hepatobiliary disorders   
Cholecystitis  1/350 (0.29%)  1
Infections and infestations   
Pneumonia  7/350 (2.00%)  10
Sepsis  3/350 (0.86%)  3
Urinary tract infection  3/350 (0.86%)  3
Diverticulitis  1/350 (0.29%)  1
Herpes zoster oticus  1/350 (0.29%)  1
Lobar pneumonia  1/350 (0.29%)  1
Localized infection  1/350 (0.29%)  1
Orchitis  1/350 (0.29%)  1
Peridiverticular abscess  1/350 (0.29%)  1
Pyelonephritis  1/350 (0.29%)  1
Urosepsis  1/350 (0.29%)  1
Viral infection  1/350 (0.29%)  1
Injury, poisoning and procedural complications   
Fall  4/350 (1.14%)  4
Hip fracture  3/350 (0.86%)  5
Skin laceration  3/350 (0.86%)  3
Femur fracture  1/350 (0.29%)  1
Head injury  1/350 (0.29%)  1
Heat stroke  1/350 (0.29%)  1
Humerus fracture  1/350 (0.29%)  1
Spinal fracture  1/350 (0.29%)  1
Subdural hemorrhage  1/350 (0.29%)  1
Traumatic intracranial hemorrhage  1/350 (0.29%)  1
Upper limb fracture  1/350 (0.29%)  1
Metabolism and nutrition disorders   
Dehydration  7/350 (2.00%)  7
Hypovolemia  2/350 (0.57%)  2
Hyponatraemia  1/350 (0.29%)  1
Musculoskeletal and connective tissue disorders   
Inter-vertebral disc protrusion  2/350 (0.57%)  2
Pain in extremity  2/350 (0.57%)  2
Back pain  1/350 (0.29%)  1
Fracture malunion  1/350 (0.29%)  1
Lumbar spinal stenosis  1/350 (0.29%)  1
Osteoarthritis  1/350 (0.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer  1/350 (0.29%)  1
Parathyroid tumor benign  1/350 (0.29%)  1
Nervous system disorders   
Syncope  10/350 (2.86%)  11
Transient ischaemic attack  3/350 (0.86%)  3
Cerebral infarct  2/350 (0.57%)  2
Multiple system atrophy  2/350 (0.57%)  2
Parkinson's disease  2/350 (0.57%)  2
Altered state of conciousness  1/350 (0.29%)  1
Brain edema  1/350 (0.29%)  1
Carotid artery thrombosis  1/350 (0.29%)  1
Cerebrovascular accident  1/350 (0.29%)  1
Encephalopathy  1/350 (0.29%)  1
Presyncopy  1/350 (0.29%)  1
Pregnancy, puerperium and perinatal conditions   
Pregnancy  1/350 (0.29%)  1
Psychiatric disorders   
Hallucination  2/350 (0.57%)  2
Mental status changes  2/350 (0.57%)  2
Suicide attempt  2/350 (0.57%)  2
Acute psychosis  1/350 (0.29%)  1
Aggression  1/350 (0.29%)  1
Depression  1/350 (0.29%)  1
Psychiatric disorder  1/350 (0.29%)  1
Renal and urinary disorders   
Urinary retention  1/350 (0.29%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1/350 (0.29%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure-  4/350 (1.14%)  4
Aspiration  3/350 (0.86%)  3
Pneumonia aspiration  3/350 (0.86%)  3
Acute respiratory failure  2/350 (0.57%)  2
Dyspnoea  2/350 (0.57%)  2
Pleural effusion  2/350 (0.57%)  2
Acute respiratory distress syndrome  1/350 (0.29%)  1
Pulmonary artery thrombosis  1/350 (0.29%)  1
Pulmonary embolism  1/350 (0.29%)  1
Pulmonary infarction  1/350 (0.29%)  1
Respiratory arrest  1/350 (0.29%)  1
Skin and subcutaneous tissue disorders   
Decubitus ulcer  2/350 (0.57%)  2
Vascular disorders   
Orthostatic hypotension  3/350 (0.86%)  3
Deep vein thrombosis  2/350 (0.57%)  3
Hypertension  2/350 (0.57%)  2
Hypertensive crisis  2/350 (0.57%)  2
Aortic aneurysm  1/350 (0.29%)  1
Aortic stenosis  1/350 (0.29%)  1
Blood pressure fluctuation  1/350 (0.29%)  1
Circulatory collapse  1/350 (0.29%)  1
Hemorrhage  1/350 (0.29%)  1
Hemorrhagic infarction  1/350 (0.29%)  1
Hypotension  1/350 (0.29%)  1
Malignant hypertension  1/350 (0.29%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Droxidopa
Affected / at Risk (%) # Events
Total   178/350 (50.86%)    
Gastrointestinal disorders   
Nausea  23/350 (6.57%)  27
General disorders   
Fatigue  28/350 (8.00%)  30
Asthenia  20/350 (5.71%)  21
Infections and infestations   
Urinary tract infection  45/350 (12.86%)  107
Injury, poisoning and procedural complications   
Fall  80/350 (22.86%)  157
Contusion  18/350 (5.14%)  40
Musculoskeletal and connective tissue disorders   
Back pain  19/350 (5.43%)  24
Nervous system disorders   
Headache  42/350 (12.00%)  59
Syncope  35/350 (10.00%)  44
Dizziness  34/350 (9.71%)  54
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Scientific Officer
Organization: Chelsea Therapeutics Inc.
Phone: 704-973-4202
Responsible Party: Chelsea Therapeutics
ClinicalTrials.gov Identifier: NCT01132326     History of Changes
Other Study ID Numbers: Droxidopa NOH304
First Submitted: September 9, 2009
First Posted: May 28, 2010
Results First Submitted: March 18, 2014
Results First Posted: April 21, 2014
Last Update Posted: March 15, 2017