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Symptomatic Neurogenic Orthostatic HypotensionPhase 4RESTORENCT02586623

Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

A Phase 4 study testing Droxidopa capsules in people with Symptomatic Neurogenic Orthostatic Hypotension, run by H. Lundbeck A/S at 168 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Droxidopa capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
453 participants
Where
168 sitesUnited States
Study dates
11 Feb 2016to 9 Sep 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older and able to stand (with or without limited assistance)
  • Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA or PAF) or NDAN or DBH Deficiency
  • Score of at least 4 or greater on Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 (measured at Screening [Visit 1] and the first Titration Visit [Visit 2a] prior to dosing)
  • A documented drop of at least 20 millimeters of mercury (mmHg) in SBP, within 3 minutes of standing. This can either be documented in the patient history or assessed during Screening prior to the first Titration Visit (Visit 2a)
  • Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care
  • Additional inclusion criteria for patients taking prescribed droxidopa prior to study entry:
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  • Patients who are taking prescribed droxidopa therapy are eligible to participate in the study if they meet the other inclusion criteria and also have been on a stable dose of prescribed droxidopa for at least 2 weeks prior to the Screening Visit (Visit 1). In addition, they must meet either of the following at the Screening Visit (Visit 1):
  • The patient's Visit 1 OHSA Item #1 score is ≥ 7 AND the prescribed dose is ≤ 300 mg three times daily (TID); OR
  • The patient's Visit 1 OHSA Item #1 score is ≤6 AND worsens by ≥ 2 units when retested after washing out of droxidopa for at least 3 days

Who cannot join

  • In the investigator's opinion, the patient is not able to understand or cooperate with study procedures
  • Known or suspected alcohol or substance use disorder within the past 12 months (DSM-5 criteria)
  • Women who are pregnant or breastfeeding
  • Women of childbearing potential (WOCP) who are not using at least one method of contraception with their partner
  • Sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic. Sustained is defined as the average of 3 observations each at least 10 minutes apart with the patient having been supine and at rest for at least 5 minutes prior to each measurement.
  • Untreated closed angle glaucoma
Show all 16Show fewer
  • Diagnosis of hypertension that requires treatment with antihypertensive medications (short-acting antihypertensives to treat nocturnal supine hypertension are allowed in this study)
  • Any significant uncontrolled cardiac arrhythmia
  • History of myocardial infarction or stroke, within the past 2 years
  • Current unstable angina
  • Congestive heart failure (NYHA Class 3 or 4)
  • Diabetic autonomic neuropathy
  • History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ
  • Any major surgical procedure within the past 30 days
  • Currently receiving any investigational drug or have received an investigational drug within the past 28 days
  • Additional protocol defined exclusion criteria do apply

Trial locations and contacts

168 sites in 1 country.

168 sites in 1 country

United States168 sites

  • Inova Health Systems

    Alexandria, Virginia, 22311

  • Peak Clinical Trials

    Apex, North Carolina, 27502

  • Baha Abu-Esheh, MD

    Ardmore, Oklahoma, 73401

  • CardioVoyage, LLC

    Ardmore, Oklahoma, 73401

  • Emory University

    Atlanta, Georgia, 30329

  • Georgia Regents University

    Augusta, Georgia, 30912

  • American Health Network of Indiana

    Avon, Indiana, 46123

  • Insight Neuroscience, LLC

    Bellevue, Ohio, 44811

  • East Bay Physicians Medical Group

    Berkeley, California, 94705

  • Sutter East Bay Medical Foundation

    Berkeley, California, 94705

  • St. Luke's Neurology Associates

    Bethlehem, Pennsylvania, 18018

  • Neurology Offices Of South Florida

    Boca Raton, Florida, 33428

  • Parkinson's Disease And Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • South Florida Neurology Associates, P.A.

    Boca Raton, Florida, 33487

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital - Movement Disorders Clinic

    Boston, Massachusetts, 02114

  • Movement Disorders Clinic

    Boston, Massachusetts, 02114

  • Autonomic and Movement Disorders

    Boston, Massachusetts, 02130

  • Brigham and Women's Faulkner Hospital (BWFH) - Brigham & Women's Foot & Ankle Center

    Boston, Massachusetts, 02130

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • iMD Medical Center

    Carrollton, Texas, 75006

  • Sunbeam Clinical Research

    Carrollton, Texas, 75006

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • MDFirst Research - Chandler

    Chandler, Arizona, 85226

  • The Neurological Institute, PA

    Charlotte, North Carolina, 28204

  • Neurosciences Institute

    Charlotte, North Carolina, 28205

  • Carolinas HealthCare System Neurosciences Institute

    Charlotte, North Carolina, 28207

  • Northwestern Medical Group

    Chicago, Illinois, 60611

  • Cardio Specialists Group, Ltd., Rush University Medical Center

    Chicago, Illinois, 60612

  • Rush University Medical Center - Department Of Cardiology

    Chicago, Illinois, 60612

  • Rush University Medical Center, Department of Neurology

    Chicago, Illinois, 60612

  • Riverhills Healthcare, Inc.

    Cincinnati, Ohio, 45219

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Cleveland Clinic - Taussig Cancer Institute

    Cleveland, Ohio, 44195

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Ohio State University, Department of Neurology

    Columbus, Ohio, 43221

  • The Ohio State University

    Columbus, Ohio, 43221

  • David L. Kreitzman MD, PC

    Commack, New York, 11725

  • Office of David L. Kreitzman, M.D., P.C.

    Commack, New York, 11725

  • Louisiana Heart Center

    Covington, Louisiana, 70433

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Associated Neurologists, P.C.

    Danbury, Connecticut, 06810

  • Michigan State University, Department of Neurology

    East Lansing, Michigan, 48824

  • JFK Neuroscience Institution

    Edison, New Jersey, 08220

  • Associated Neurologists of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • Integrated Neurology Services, PLLC

    Falls Church, Virginia, 22043

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48334

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48334

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • The Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708

  • UF Center for Movement Disorders and Neurorestoration

    Gainesville, Florida, 32607

  • Neurological Center of North Georgia

    Gainesville, Georgia, 30501

  • The Neurological Center of North Georgia

    Gainesville, Georgia, 30501

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • NorthShore Neurological Institute

    Glenview, Illinois, 60026

  • Aurora Medical Center

    Grafton, Wisconsin, 53024

  • Grafton Medical Office

    Grafton, Wisconsin, 53024

  • Elite Primary Care

    Greenville, Texas, 75401

  • Sunbeam Clinical Research

    Greenville, Texas, 75401

  • Mir Neurology

    Hagerstown, Maryland, 21740

  • Neurology Associates of West Chester

    Hawthorne, New York, 10532

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17025

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Galiz Research

    Hialeah, Florida, 33016

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Franciscan Physician Network Indiana Heart Physicians

    Indianapolis, Indiana, 46237

  • Mid America Cardiology - University of Kansas

    Kansas City, Kansas, 66160

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Platte Valley Medical Group

    Kearney, Nebraska, 68845

  • Booth Gardner Parkinson's Care Center

    Kirkland, Washington, 98034

  • SIH Research

    Kissimmee, Florida, 34759

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Arkansas Cardiology Clinic

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • University Of Southern California

    Los Angeles, California, 90033

  • Neurology Associates

    Maitland, Florida, 32751

  • Eastern Connecticut Neurology Specialists, LLC

    Manchester, Connecticut, 06040

  • Texas Institute of Cardiology, The Heartbeat Clinic

    McKinney, Texas, 75069

  • The Heartbeat Clinic

    McKinney, Texas, 75069

  • Future Clinical Research

    Miami, Florida, 33122

  • Project 4 Research

    Miami, Florida, 33125

  • Premium Medical Research, Corp

    Miami, Florida, 33126

  • University Of Miami - Jackson Memorial Hospital, Dept. of Neurology

    Miami, Florida, 33136

  • Coral Way Research

    Miami, Florida, 33155

  • Florida Research Center

    Miami, Florida, 33174

  • Anchor Medical Research, LLC

    Miami, Florida, 33176

  • Novel Clinical Research Center, LLC

    Miami, Florida, 33186

  • Pro-Care Research Center, Corporation

    Miami Gardens, Florida, 33014

  • New Life Medical Research Center

    Miami Lakes, Florida, 33014

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin, Department of Neurology

    Milwaukee, Wisconsin, 53226

  • Aurora Sinai Medical Center-Arrhythmia Center

    Milwaukee, Wisconsin, 53233

  • Parkinson's Institute and Clinical Center

    Mountain View, California, 94040

  • Vanderbilt University Autonomic Dysfunction Center - Clinical Trials Center

    Nashville, Tennessee, 37232

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale Neurology / Hypertension Program

    New Haven, Connecticut, 06519

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • Parker Jewish Institute for Health Care & Rehabilitation

    New Hyde Park, New York, 11040

  • Weill Cornell Medical College, Dept. of Neurology

    New York, New York, 10021

  • The Bendheim Parkinson and Movement Disorders Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Project 4 Research, Inc., The Neurological Institute at Columbia University Medical Center

    New York, New York, 10032

  • The Neurological Institute at Columbia University Medical Center

    New York, New York, 10032

  • Parker Jewish Institute For Healthcare And Rehabilitation

    New York, New York, 11542

  • Christiana Care Neurology Specialists

    Newark, Delaware, 19713

  • Health Research of Hampton Roads-Norfolk, Inc

    Norfolk, Virginia, 23502

  • Sentara Neurology Specialists

    Norfolk, Virginia, 23507

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Methodist Physicians Clinic - Heart Consultants

    Omaha, Nebraska, 68114

  • MPC Heart Consultants

    Omaha, Nebraska, 68114

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198-8435

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Diverse Research Solutions, LLC

    Oxnard, California, 93030

  • Focilmed

    Oxnard, California, 93030

  • Parkinsons Disease & Movement Disorder of Silicon Valley

    Palo Alto, California, 94301

  • Neurosearch, Inc. - Pasedena

    Pasadena, California, 91105

  • Neurosearch, Inc. - Ventura

    Pasadena, California, 91105

  • SC3 Research Group

    Pasadena, California, 91105

  • Drexel Neurosciences Institute

    Philadelphia, Pennsylvania, 19102

  • University of Pennsylvania, Parkinson's Disease & Movement Disorders Center

    Philadelphia, Pennsylvania, 19107

  • 21st Century Neurology

    Phoenix, Arizona, 85004

  • University of Pittsburgh, Department of Neurology

    Pittsburgh, Pennsylvania, 15213

  • Island Neurological Associates

    Plainview, New York, 11803

  • Neurostudies, Inc.

    Port Charlotte, Florida, 33952

  • Parkinson's Disease Treatment Center of Southwest Florida

    Port Charlotte, Florida, 33952

  • Legacy / Oregon Clinic Neurology

    Portland, Oregon, 97210

  • The Oregon Clinic

    Portland, Oregon, 97210

  • Sunbeam Clinical Research, LLC.

    Prosper, Texas, 75078

  • Dr. Umer Akbar MD, Office of

    Providence, Rhode Island, 02903

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

  • Neurosearch, Inc. - Reseda

    Reseda, California, 91335

  • Henrico Doctors Neurology Associates, LLC

    Richmond, Virginia, 23226

  • Carilion Clinic

    Roanoke, Virginia, 24016

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Radiological Associates of Sacramento

    Sacramento, California, 95815

  • Sutter Neuroscience

    Sacramento, California, 95816

  • Bateman Home Center

    Salt Lake City, Utah, 84102

  • Maine Medical Partners Technology

    Scarborough, Maine, 04074

  • Movement Disorders Center of Arizona

    Scottsdale, Arizona, 85258

  • Northwest Neurology, Premier Clinical Research

    Spokane, Washington, 99202

  • Premeir Clinical Research

    Spokane, Washington, 99202

  • Alpha Neurology

    Staten Island, New York, 10306

  • The Parkinson's Institute and Clinical Center

    Sunnyvale, California, 94085

  • Eminance Medical & Clinical Research

    Tampa, Florida, 33604

  • University Of South Florida

    Tampa, Florida, 33613

  • USF Parkinson's & Movement Disorders Center

    Tampa, Florida, 33613

  • Gardner-McMaster Parkinson Center - The University of Toledo

    Toledo, Ohio, 43614

  • Medical College of Ohio, Department of Neurology

    Toledo, Ohio, 43614

  • Neuroscience Research Institute, LLC

    Toms River, New Jersey, 08755

  • Neurosearch Inc. - Torrance

    Torrance, California, 90505

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Nothern Michigan Neurology

    Traverse City, Michigan, 49684

  • Center For Neurosciences

    Tucson, Arizona, 85718

  • Movement Disorder Clinic - The University of Arizona

    Tucson, Arizona, 85724-5023

  • University of Arizona Health Sciences Center, Department Of Neurology

    Tucson, Arizona, 85724

  • Christus Research Institute

    Tyler, Texas, 75701

  • Vero Neurology

    Vero Beach, Florida, 32960

  • Geodyssey Research, LLC

    Vero Beach, Florida, 32962

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)

    Washington D.C., District of Columbia, 20007

  • Clear Lake Specialties

    Webster, Texas, 77598

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • Helen Hayes Hospital

    West Haverstraw, New York, 10093

  • UBMD Neurology

    Williamsville, New York, 14221

  • Central Dupage Hospital

    Winfield, Illinois, 60190

  • Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

Other trials in United States

About this study

Official title: RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy

To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)

Read the detailed description

This is a multi-site, placebo-controlled, double-blind, randomized withdrawal, time to intervention study with a duration of up to 36 weeks, consisting of 5 periods:

Screening Period: up to 4 weeks duration; Open-Label Titration Period (Titration Period): up to 4 weeks duration; Open-Label Treatment Period (Open-Label Period): 12 weeks duration; Double-Blind Treatment Period (Double-Blind Period): 12 weeks duration; Safety Follow-Up Period: 4 weeks duration

Being tested
Droxidopa capsules, Placebo capsules
Keywords
Parkinson's Disease, Multiple System Atrophy, Pure Autonomic Failure, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency
Medical subject headings
Parkinson Disease, Multiple System Atrophy, Pure Autonomic Failure, dopamine beta hydroxylase deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Droxidopa capsulesDrug

    Also called Northera

    100, 200 or 300 mg

  • Placebo capsulesDrug

    Also called Placebo

Study groups in NCT02586623
Study groupRoleWhat they receive
Open Label PeriodExperimentalActive 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).
Receives: Drug: Droxidopa capsules
Randomized PeriodPlacebo comparatorActive 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.
Receives: Drug: Droxidopa capsules; Drug: Placebo capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time To Intervention

    Kaplan-Meier estimates are presented for time to treatment intervention. The estimates represent the quartiles of the survival time, where 50% corresponds to the median time to need for treatment intervention.

    Need for intervention is defined as meeting ANY of the following criteria during the Double-Blind Treatment Period:

    • OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) AND lack of efficacy as judged by the investigator; OR
    • OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) at 2 consecutive visits; OR
    • OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) at the visit before early discontinuation; OR
    • participant stops IMP or withdraws from study for patient-reported lack of efficacy.

    Measured: Randomization (Day 0) up to Week 12

Secondary outcomes (6)

  1. Number of Participants Who Needed Intervention During the 12-week Double-Blind Treatment Period

    Need for intervention is defined as meeting ANY of the following criteria during the Double-Blind Treatment Period:

    • OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) AND lack of efficacy as judged by the investigator; OR
    • OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) at 2 consecutive visits; OR
    • OHSA Item #1 ≥2 unit worsening from Randomization (Visit 6) at the visit before early discontinuation; OR
    • participant stops IMP or withdraws from study for patient-reported lack of efficacy.

    Measured: Randomization (Day 0) up to Week 12

  2. Time To All-cause Discontinuation

    Kaplan-Meier estimates are presented for time to all-cause discontinuation. The estimates represent the quartiles of the survival time, where 50% corresponds to the median time to discontinuation. Time to all-cause discontinuation was defined as the time from randomization to withdrawal or last contact date.

    Measured: Randomization (Day 0) up to Week 12

  3. Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 Score

    The OHSA scale was designed to rate symptoms occurring specifically as a result of low blood pressure (BP), on average, over the past week using an 11-point scale (0 to 10), with more severe symptoms scoring higher. A score of zero indicates that the symptom was not experienced, and 10 is the worst possible. The scale was used to assess six symptoms: 1) Dizziness, lightheadedness, feeling faint, or feeling like you might black out, 2) problems with vision, 3) weakness, 4) fatigue, 5) trouble concentrating, and 6) head/neck discomfort. Scores for each activity and a composite score for all six activities were tabulated. A mean negative change from baseline means that symptoms have improved. A mean positive change from baseline means that symptoms have gotten worse.

    Measured: Randomization (Day 0); Weeks 2 to 12

  4. Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Questionnaire (OHQ) Composite Score

    The OHQ composite score was a mean of the OHSA composite and the Orthostatic Hypotension Daily Activity Scale (OHDAS) composite scores. The OHDAS was designed as a measure of quality of life. It uses an 11-point scale to assess whether orthostatic hypotension (OH) "interfered" with four types of activities: 1) standing for a short time, 2) standing for a long time, 3) walking for a short time, and 4) walking for a long time. A zero rating means that over the preceding week the activity was performed with no interference and a 10 rating means that orthostatic hypotension completely interfered with the activity. Scores for each activity and a composite score for all four activities were tabulated. A mean negative change from baseline means that symptoms have improved. A mean positive change from baseline means that symptoms have gotten worse.

    Measured: Randomization (Day 0); Weeks 2 to 12

  5. Clinician-rated Clinical Global Impressions - Severity (CGI-S)

    The CGI-S was developed to provide global measures of the severity of a participant's clinical condition during clinical studies. The CGI-S was utilized by both the clinician and the participant to provide an impression of the participant's current state of OH. The severity of the participant's current illness was rated by the clinician on a 7-point scale ranging from 1 (normal, no OH) to 7 (among those patients most extremely ill with OH).

    Measured: Weeks 2 to 12

  6. Participant-rated CGI-S

    The CGI-S was developed to provide global measures of the severity of a participant's clinical condition during clinical studies. The CGI-S was utilized by both the clinician and the participant to provide an impression of the participant's current state of OH. The severity of the participant's current illness was rated by the participant on a 7-point scale ranging from 1 (normal, no OH) to 7 (most extremely ill with OH).

    Measured: Weeks 2 to 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study start11 Feb 2016
  3. Primary completion21 Jul 2022
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586623
Sponsor's protocol ID
16306A
Other IDs
NOH402
Acronym
RESTORE
Status last verified
Aug 2023
First submitted
23 Oct 2015
Last updated
23 Aug 2023
Data monitoring committee
No

Publications

  • Hauser RA, Favit A, Hewitt LA, Lindsten A, Gorny S, Kymes S, Isaacson SH. Durability of the Clinical Benefit of Droxidopa for Neurogenic Orthostatic Hypotension During 12 Weeks of Open-Label Treatment. Neurol Ther. 2022 Mar;11(1):459-469. doi: 10.1007/s40120-021-00317-5. Epub 2022 Feb 2.

    PubMed 35107750

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Droxidopa capsules in people with Symptomatic Neurogenic Orthostatic Hypotension, run by H. Lundbeck A/S at 168 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time To Intervention (time frame: Randomization (Day 0) up to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02586623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.

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