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Norepinephrine Precursor

Droxidopa capsules for Neurogenic Orthostatic Hypotension (RESTORE Trial)

Phase 4
Waitlist Available
Research Sponsored by Lundbeck Northera Ltd.
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 weeks 2 to 12
Awards & highlights

RESTORE Trial Summary

This study is evaluating whether a medication which helps treat Parkinson's disease may also help treat other conditions which cause dizziness.

Eligible Conditions
  • Neurogenic Orthostatic Hypotension

RESTORE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization (day 0); weeks 2 to 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization (day 0); weeks 2 to 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time To Intervention
Secondary outcome measures
Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Questionnaire (OHQ) Composite Score
Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 Score
Clinician-rated Clinical Global Impressions - Severity (CGI-S)
+3 more

Side effects data

From 2022 Phase 4 trial • 453 Patients • NCT02586623
15%
Headache
11%
Fall
10%
Nausea
9%
Dizziness
6%
Urinary tract infection
5%
Hypertension
5%
Fatigue
1%
Pneumonia aspiration
1%
Cerebral haemorrhage
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Placebo
Open-Label Droxidopa
Double-Blind Droxidopa

RESTORE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label PeriodExperimental Treatment1 Intervention
Active droxidopa 100, 200, 300, 400, 500, or 600 mg three times daily (TID) orally. During the Open Label Titration Period, patients will first receive 100 mg TID and their dose will be raised (in 100 mg increments) at subsequent visits until optimal dose is determined. During the Open Label Treatment Period, patients will receive active droxidopa100, 200, 300, 400, 500, or 600 mg three times daily (TID) orally (equal to the patient's individual dose at the end of the Open-Label Titration Period).
Group II: Randomized PeriodPlacebo Group2 Interventions
Active droxidopa 100, 200, 300, 400, 500, or 600 mg three times daily (TID) orally (equal to patients individual dose at the end of the Open-Label Period) or matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Droxidopa capsules
2016
Completed Phase 4
~460

Find a Location

Who is running the clinical trial?

Lundbeck Northera Ltd.Lead Sponsor
H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,130 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorLundbeckClinicalTrials@Lundbeck.com
188 Previous Clinical Trials
57,887 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
2016. "Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02586623.
~49 spots leftby Apr 2025
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