Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
RESTORE
RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
2 other identifiers
interventional
453
1 country
168
Brief 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 neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2016
Longer than P75 for phase_4
168 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedStudy Start
First participant enrolled
February 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2022
CompletedResults Posted
Study results publicly available
August 23, 2023
CompletedAugust 23, 2023
August 1, 2023
6.4 years
October 23, 2015
July 20, 2023
August 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Randomization (Day 0) up to Week 12
Secondary Outcomes (6)
Number of Participants Who Needed Intervention During the 12-week Double-Blind Treatment Period
Randomization (Day 0) up to Week 12
Time To All-cause Discontinuation
Randomization (Day 0) up to Week 12
Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 Score
Randomization (Day 0); Weeks 2 to 12
Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Questionnaire (OHQ) Composite Score
Randomization (Day 0); Weeks 2 to 12
Clinician-rated Clinical Global Impressions - Severity (CGI-S)
Weeks 2 to 12
- +1 more secondary outcomes
Study Arms (2)
Open Label Period
EXPERIMENTALActive 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).
Randomized Period
PLACEBO 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (168)
MDFirst Research - Chandler
Chandler, Arizona, 85226, United States
21st Century Neurology
Phoenix, Arizona, 85004, United States
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258, United States
Center For Neurosciences
Tucson, Arizona, 85718, United States
Movement Disorder Clinic - The University of Arizona
Tucson, Arizona, 85724-5023, United States
University of Arizona Health Sciences Center, Department Of Neurology
Tucson, Arizona, 85724, United States
Arkansas Cardiology Clinic
Little Rock, Arkansas, 72205, United States
East Bay Physicians Medical Group
Berkeley, California, 94705, United States
Sutter East Bay Medical Foundation
Berkeley, California, 94705, United States
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University Of Southern California
Los Angeles, California, 90033, United States
Parkinson's Institute and Clinical Center
Mountain View, California, 94040, United States
Diverse Research Solutions, LLC
Oxnard, California, 93030, United States
Focilmed
Oxnard, California, 93030, United States
Parkinsons Disease & Movement Disorder of Silicon Valley
Palo Alto, California, 94301, United States
Neurosearch, Inc. - Pasedena
Pasadena, California, 91105, United States
Neurosearch, Inc. - Ventura
Pasadena, California, 91105, United States
SC3 Research Group
Pasadena, California, 91105, United States
Neurosearch, Inc. - Reseda
Reseda, California, 91335, United States
Radiological Associates of Sacramento
Sacramento, California, 95815, United States
Sutter Neuroscience
Sacramento, California, 95816, United States
The Parkinson's Institute and Clinical Center
Sunnyvale, California, 94085, United States
Neurosearch Inc. - Torrance
Torrance, California, 90505, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Associated Neurologists, P.C.
Danbury, Connecticut, 06810, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, 06824, United States
Eastern Connecticut Neurology Specialists, LLC
Manchester, Connecticut, 06040, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale Neurology / Hypertension Program
New Haven, Connecticut, 06519, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
Christiana Care Neurology Specialists
Newark, Delaware, 19713, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, 20007, United States
Neurology Offices Of South Florida
Boca Raton, Florida, 33428, United States
Parkinson's Disease And Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
South Florida Neurology Associates, P.A.
Boca Raton, Florida, 33487, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
UF Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607, United States
Galiz Research
Hialeah, Florida, 33016, United States
SIH Research
Kissimmee, Florida, 34759, United States
Neurology Associates
Maitland, Florida, 32751, United States
Future Clinical Research
Miami, Florida, 33122, United States
Project 4 Research
Miami, Florida, 33125, United States
Premium Medical Research, Corp
Miami, Florida, 33126, United States
University Of Miami - Jackson Memorial Hospital, Dept. of Neurology
Miami, Florida, 33136, United States
Coral Way Research
Miami, Florida, 33155, United States
Florida Research Center
Miami, Florida, 33174, United States
Anchor Medical Research, LLC
Miami, Florida, 33176, United States
Novel Clinical Research Center, LLC
Miami, Florida, 33186, United States
Pro-Care Research Center, Corporation
Miami Gardens, Florida, 33014, United States
New Life Medical Research Center
Miami Lakes, Florida, 33014, United States
Neurostudies, Inc.
Port Charlotte, Florida, 33952, United States
Parkinson's Disease Treatment Center of Southwest Florida
Port Charlotte, Florida, 33952, United States
Eminance Medical & Clinical Research
Tampa, Florida, 33604, United States
University Of South Florida
Tampa, Florida, 33613, United States
USF Parkinson's & Movement Disorders Center
Tampa, Florida, 33613, United States
Vero Neurology
Vero Beach, Florida, 32960, United States
Geodyssey Research, LLC
Vero Beach, Florida, 32962, United States
Emory University
Atlanta, Georgia, 30329, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Neurological Center of North Georgia
Gainesville, Georgia, 30501, United States
The Neurological Center of North Georgia
Gainesville, Georgia, 30501, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
Cardio Specialists Group, Ltd., Rush University Medical Center
Chicago, Illinois, 60612, United States
Rush University Medical Center - Department Of Cardiology
Chicago, Illinois, 60612, United States
Rush University Medical Center, Department of Neurology
Chicago, Illinois, 60612, United States
NorthShore Neurological Institute
Glenview, Illinois, 60026, United States
Central Dupage Hospital
Winfield, Illinois, 60190, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190, United States
American Health Network of Indiana
Avon, Indiana, 46123, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Franciscan Physician Network Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
Mid America Cardiology - University of Kansas
Kansas City, Kansas, 66160, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Louisiana Heart Center
Covington, Louisiana, 70433, United States
Maine Medical Partners Technology
Scarborough, Maine, 04074, United States
Mir Neurology
Hagerstown, Maryland, 21740, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital - Movement Disorders Clinic
Boston, Massachusetts, 02114, United States
Movement Disorders Clinic
Boston, Massachusetts, 02114, United States
Autonomic and Movement Disorders
Boston, Massachusetts, 02130, United States
Brigham and Women's Faulkner Hospital (BWFH) - Brigham & Women's Foot & Ankle Center
Boston, Massachusetts, 02130, United States
Michigan State University, Department of Neurology
East Lansing, Michigan, 48824, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334, United States
Northern Michigan Neurology
Traverse City, Michigan, 49684, United States
Nothern Michigan Neurology
Traverse City, Michigan, 49684, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Platte Valley Medical Group
Kearney, Nebraska, 68845, United States
Methodist Physicians Clinic - Heart Consultants
Omaha, Nebraska, 68114, United States
MPC Heart Consultants
Omaha, Nebraska, 68114, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198-8435, United States
The Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
JFK Neuroscience Institution
Edison, New Jersey, 08220, United States
Neuroscience Research Institute, LLC
Toms River, New Jersey, 08755, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
David L. Kreitzman MD, PC
Commack, New York, 11725, United States
Office of David L. Kreitzman, M.D., P.C.
Commack, New York, 11725, United States
Neurology Associates of West Chester
Hawthorne, New York, 10532, United States
Parker Jewish Institute for Health Care & Rehabilitation
New Hyde Park, New York, 11040, United States
Weill Cornell Medical College, Dept. of Neurology
New York, New York, 10021, United States
The Bendheim Parkinson and Movement Disorders Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Project 4 Research, Inc., The Neurological Institute at Columbia University Medical Center
New York, New York, 10032, United States
The Neurological Institute at Columbia University Medical Center
New York, New York, 10032, United States
Parker Jewish Institute For Healthcare And Rehabilitation
New York, New York, 11542, United States
Island Neurological Associates
Plainview, New York, 11803, United States
Alpha Neurology
Staten Island, New York, 10306, United States
Helen Hayes Hospital
West Haverstraw, New York, 10093, United States
UBMD Neurology
Williamsville, New York, 14221, United States
Peak Clinical Trials
Apex, North Carolina, 27502, United States
The Neurological Institute, PA
Charlotte, North Carolina, 28204, United States
Neurosciences Institute
Charlotte, North Carolina, 28205, United States
Carolinas HealthCare System Neurosciences Institute
Charlotte, North Carolina, 28207, United States
Insight Neuroscience, LLC
Bellevue, Ohio, 44811, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Riverhills Healthcare, Inc.
Cincinnati, Ohio, 45219, United States
Cleveland Clinic - Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Ohio State University, Department of Neurology
Columbus, Ohio, 43221, United States
The Ohio State University
Columbus, Ohio, 43221, United States
Gardner-McMaster Parkinson Center - The University of Toledo
Toledo, Ohio, 43614, United States
Medical College of Ohio, Department of Neurology
Toledo, Ohio, 43614, United States
Baha Abu-Esheh, MD
Ardmore, Oklahoma, 73401, United States
CardioVoyage, LLC
Ardmore, Oklahoma, 73401, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Legacy / Oregon Clinic Neurology
Portland, Oregon, 97210, United States
The Oregon Clinic
Portland, Oregon, 97210, United States
St. Luke's Neurology Associates
Bethlehem, Pennsylvania, 18018, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17025, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Drexel Neurosciences Institute
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania, Parkinson's Disease & Movement Disorders Center
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh, Department of Neurology
Pittsburgh, Pennsylvania, 15213, United States
Dr. Umer Akbar MD, Office of
Providence, Rhode Island, 02903, United States
Rhode Island Hospital
Providence, Rhode Island, 02905, United States
Vanderbilt University Autonomic Dysfunction Center - Clinical Trials Center
Nashville, Tennessee, 37232, United States
iMD Medical Center
Carrollton, Texas, 75006, United States
Sunbeam Clinical Research
Carrollton, Texas, 75006, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Elite Primary Care
Greenville, Texas, 75401, United States
Sunbeam Clinical Research
Greenville, Texas, 75401, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Texas Institute of Cardiology, The Heartbeat Clinic
McKinney, Texas, 75069, United States
The Heartbeat Clinic
McKinney, Texas, 75069, United States
Sunbeam Clinical Research, LLC.
Prosper, Texas, 75078, United States
Central Texas Neurology Consultants
Round Rock, Texas, 78681, United States
Christus Research Institute
Tyler, Texas, 75701, United States
Clear Lake Specialties
Webster, Texas, 77598, United States
Bateman Home Center
Salt Lake City, Utah, 84102, United States
Inova Health Systems
Alexandria, Virginia, 22311, United States
Integrated Neurology Services, PLLC
Falls Church, Virginia, 22043, United States
Health Research of Hampton Roads-Norfolk, Inc
Norfolk, Virginia, 23502, United States
Sentara Neurology Specialists
Norfolk, Virginia, 23507, United States
Henrico Doctors Neurology Associates, LLC
Richmond, Virginia, 23226, United States
Carilion Clinic
Roanoke, Virginia, 24016, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034, United States
Northwest Neurology, Premier Clinical Research
Spokane, Washington, 99202, United States
Premeir Clinical Research
Spokane, Washington, 99202, United States
Aurora Medical Center
Grafton, Wisconsin, 53024, United States
Grafton Medical Office
Grafton, Wisconsin, 53024, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin, Department of Neurology
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center-Arrhythmia Center
Milwaukee, Wisconsin, 53233, United States
Related Publications (1)
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.
PMID: 35107750DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Email contact via
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2015
First Posted
October 26, 2015
Study Start
February 11, 2016
Primary Completion
July 21, 2022
Study Completion
September 9, 2022
Last Updated
August 23, 2023
Results First Posted
August 23, 2023
Record last verified: 2023-08