Trial Outcomes & Findings for Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) (NCT NCT01132326)
NCT ID: NCT01132326
Last Updated: 2024-02-09
Results Overview
Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
up to 2 years
Results posted on
2024-02-09
Participant Flow
Participant milestones
| Measure |
Droxidopa
Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
|
|---|---|
|
Overall Study
STARTED
|
350
|
|
Overall Study
COMPLETED
|
132
|
|
Overall Study
NOT COMPLETED
|
218
|
Reasons for withdrawal
| Measure |
Droxidopa
Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
|
|---|---|
|
Overall Study
Lack of Efficacy
|
25
|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Withdrawal by Subject
|
40
|
|
Overall Study
Physician Decision
|
10
|
|
Overall Study
Study Termination
|
80
|
|
Overall Study
Declining Health
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Caregiver Withdrew Consent
|
1
|
|
Overall Study
Death
|
5
|
|
Overall Study
Subject Unable to Come To Visits
|
1
|
Baseline Characteristics
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304)
Baseline characteristics by cohort
| Measure |
Droxidopa
n=350 Participants
Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
|
|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 15.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
344 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
263 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
87 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Parkinson's Disease
|
232 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Multiple System Atrophy
|
33 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Pure Autonomic Failure
|
68 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Dopamine Beta-Hydroxylase Deficiency
|
0 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Non-Diabetic Autonomic Neuropathy
|
8 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Other
|
7 participants
n=5 Participants
|
|
Primary Clinical Diagnosis
Missing
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsNumber of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study
Outcome measures
| Measure |
Droxidopa
n=350 Participants
Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
|
|---|---|
|
Patients With Treatment-emergent Adverse Events
|
263 participants
|
Adverse Events
Droxidopa
Serious events: 83 serious events
Other events: 178 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Droxidopa
n=350 participants at risk
Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
|
|---|---|
|
Nervous system disorders
Syncope
|
2.9%
10/350 • Number of events 11
|
|
Nervous system disorders
Transient ischaemic attack
|
0.86%
3/350 • Number of events 3
|
|
Nervous system disorders
Cerebral infarct
|
0.57%
2/350 • Number of events 2
|
|
Nervous system disorders
Multiple system atrophy
|
0.57%
2/350 • Number of events 2
|
|
Nervous system disorders
Parkinson's disease
|
0.57%
2/350 • Number of events 2
|
|
Nervous system disorders
Altered state of conciousness
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Brain edema
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Encephalopathy
|
0.29%
1/350 • Number of events 1
|
|
Nervous system disorders
Presyncopy
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.0%
7/350 • Number of events 10
|
|
Infections and infestations
Sepsis
|
0.86%
3/350 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
0.86%
3/350 • Number of events 3
|
|
Infections and infestations
Diverticulitis
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Herpes zoster oticus
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Localized infection
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Orchitis
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Peridiverticular abscess
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.29%
1/350 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
4/350 • Number of events 4
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.86%
3/350 • Number of events 5
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.86%
3/350 • Number of events 3
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head injury
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Subdural hemorrhage
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Traumatic intracranial hemorrhage
|
0.29%
1/350 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Orthostatic hypotension
|
0.86%
3/350 • Number of events 3
|
|
Vascular disorders
Deep vein thrombosis
|
0.57%
2/350 • Number of events 3
|
|
Vascular disorders
Hypertension
|
0.57%
2/350 • Number of events 2
|
|
Vascular disorders
Hypertensive crisis
|
0.57%
2/350 • Number of events 2
|
|
Vascular disorders
Aortic aneurysm
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Blood pressure fluctuation
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Circulatory collapse
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Hemorrhagic infarction
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.29%
1/350 • Number of events 1
|
|
Vascular disorders
Malignant hypertension
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure-
|
1.1%
4/350 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.86%
3/350 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.86%
3/350 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.57%
2/350 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.57%
2/350 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.57%
2/350 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.29%
1/350 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.29%
1/350 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.57%
2/350 • Number of events 2
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.57%
2/350 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
0.57%
2/350 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
0.29%
1/350 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.29%
1/350 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/350 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/350 • Number of events 1
|
|
Cardiac disorders
Supra-ventricular tachycardia
|
0.29%
1/350 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
7/350 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.57%
2/350 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Asthenia
|
0.86%
3/350 • Number of events 3
|
|
General disorders
Non-cardiac chest pain
|
0.57%
2/350 • Number of events 2
|
|
General disorders
Chest discomfort
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Chest pain
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.29%
1/350 • Number of events 1
|
|
General disorders
Hyperthermia
|
0.29%
1/350 • Number of events 1
|
|
Psychiatric disorders
Hallucination
|
0.57%
2/350 • Number of events 2
|
|
Psychiatric disorders
Mental status changes
|
0.57%
2/350 • Number of events 2
|
|
Psychiatric disorders
Suicide attempt
|
0.57%
2/350 • Number of events 2
|
|
Psychiatric disorders
Acute psychosis
|
0.29%
1/350 • Number of events 1
|
|
Psychiatric disorders
Aggression
|
0.29%
1/350 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.29%
1/350 • Number of events 1
|
|
Psychiatric disorders
Psychiatric disorder
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.57%
2/350 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.57%
2/350 • Number of events 2
|
|
Gastrointestinal disorders
Colitis ischemia
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.29%
1/350 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.29%
1/350 • Number of events 2
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Inter-vertebral disc protrusion
|
0.57%
2/350 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.57%
2/350 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.29%
1/350 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.29%
1/350 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.29%
1/350 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumor benign
|
0.29%
1/350 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.57%
2/350 • Number of events 2
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.29%
1/350 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.29%
1/350 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/350 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.29%
1/350 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.29%
1/350 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.29%
1/350 • Number of events 1
|
Other adverse events
| Measure |
Droxidopa
n=350 participants at risk
Open-Label Droxidopa
Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
|
|---|---|
|
Nervous system disorders
Headache
|
12.0%
42/350 • Number of events 59
|
|
Nervous system disorders
Syncope
|
10.0%
35/350 • Number of events 44
|
|
Nervous system disorders
Dizziness
|
9.7%
34/350 • Number of events 54
|
|
Injury, poisoning and procedural complications
Fall
|
22.9%
80/350 • Number of events 157
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
18/350 • Number of events 40
|
|
Infections and infestations
Urinary tract infection
|
12.9%
45/350 • Number of events 107
|
|
Gastrointestinal disorders
Nausea
|
6.6%
23/350 • Number of events 27
|
|
General disorders
Fatigue
|
8.0%
28/350 • Number of events 30
|
|
General disorders
Asthenia
|
5.7%
20/350 • Number of events 21
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
19/350 • Number of events 24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60