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Norepinephrine Precursor
Study 1: Dose Optimization of Northera for Spinal Cord Injury
Phase 4
Waitlist Available
Led By Jill M Wecht, Ed.D
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 to 120 minutes following administration of droxidopa
Awards & highlights
Study Summary
Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury
Eligible Conditions
- Spinal Cord Injury
- Orthostatic Hypotension
- Low Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 to 120 minutes following administration of droxidopa
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 to 120 minutes following administration of droxidopa
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with normotensive systolic blood pressure
Secondary outcome measures
Change in cerebral blood flow
Orthostatic systolic Blood Pressure
Supine systolic blood pressure
Side effects data
From 2018 Phase 4 trial • 15 Patients • NCT0311582713%
Nausea
7%
Palpitations
7%
Influenza-like symptoms
7%
Conjunctival Hemhorrage
7%
Increased Uncoordinated Movements
7%
transient cholecystitis
7%
Brief Confusional Episode
7%
Increased Foot Dystonia
7%
ventral hernia
7%
Increased Freezing
7%
Dry Mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 1: Dose Optimization of NortheraExperimental Treatment1 Intervention
Subjects will be administered oral droxidopa in a dose escalation, open-label manner beginning with 200 mg. The dose will be adjusted upwards by 100 mg on subsequent visits until average Systolic Blood Pressure (SBP) recorded 60-120 minutes after dose administration is 111-139 mmHg in males and 101-139 mmHg in females, sustained elevation (≥ 30 consecutive minutes) in seated SBP ≥ 140/100 mmHg, maximum dose of 800 mg is reached without adequate SBP response. Subjects will visit the testing laboratory on as few as 1 (200 mg) and as many as 7 (800 mg) days. Seated cardiovascular assessments will be monitored and recorded at 15-minute intervals for 4-hours, and the side effects questionnaire will be administered hourly during the 4-hour study. Each study visit will take about 5 hours.
Group II: Study 2: Blinded Placebo & NortheraPlacebo Group2 Interventions
Participants will then be administered either oral optimal dose of Northera (Droxidopa) or matching placebo in a double-blinded manner and will remain in the supine position for 60 minutes. Subjects will remain in their wheelchair for instrumentation, which will include: 1) ECG, 2) brachial BP, 3) finger arteriolar BP and 4) Cerebral Blood Flow velocity (CBFv).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Droxidopa
FDA approved
Find a Location
Who is running the clinical trial?
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,878 Total Patients Enrolled
New York State Department of HealthOTHER_GOV
34 Previous Clinical Trials
447,075 Total Patients Enrolled
Jill M Wecht, Ed.DPrincipal InvestigatorJames J. Peter's VAMC
2 Previous Clinical Trials
101 Total Patients Enrolled
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