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

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)

Study Overview

• Status: Completed
• Conditions: Symptomatic Neurogenic Orthostatic Hypotension
• Intervention / Treatment: Drug: Placebo capsules; Drug: Droxidopa capsules

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

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85226
      • MDFirst Research - Chandler
    • Phoenix, Arizona, United States, 85004
      • 21st Century Neurology
    • Scottsdale, Arizona, United States, 85258
      • Movement Disorders Center of Arizona
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
    • Tucson, Arizona, United States, 85724-5023
      • Movement Disorder Clinic - The University of Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Health Sciences Center, Department Of Neurology
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cardiology Clinic
  • California
    • Berkeley, California, United States, 94705
      • East Bay Physicians Medical Group
    • Berkeley, California, United States, 94705
      • Sutter East Bay Medical Foundation
    • Fountain Valley, California, United States, 92708
      • The Parkinson's and Movement Disorder Institute
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Mountain View, California, United States, 94040
      • Parkinson's Institute and Clinical Center
    • Oxnard, California, United States, 93030
      • FocilMed
    • Oxnard, California, United States, 93030
      • Diverse Research Solutions, LLC
    • Palo Alto, California, United States, 94301
      • Parkinsons Disease & Movement Disorder of Silicon Valley
    • Pasadena, California, United States, 91105
      • SC3 Research Group
    • Pasadena, California, United States, 91105
      • Neurosearch, Inc. - Pasedena
    • Pasadena, California, United States, 91105
      • Neurosearch, Inc. - Ventura
    • Reseda, California, United States, 91335
      • Neurosearch, Inc. - Reseda
    • Sacramento, California, United States, 95815
      • Radiological Associates of Sacramento
    • Sacramento, California, United States, 95816
      • Sutter Neuroscience
    • Sunnyvale, California, United States, 94085
      • The Parkinson's Institute and Clinical Center
    • Torrance, California, United States, 90505
      • Neurosearch Inc. - Torrance
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Neurologists, P.C.
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut, P.C.
    • Manchester, Connecticut, United States, 06040
      • Eastern Connecticut Neurology Specialists, LLC
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital
    • New Haven, Connecticut, United States, 06519
      • Yale Neurology / Hypertension Program
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Neurology Specialists
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
  • Florida
    • Boca Raton, Florida, United States, 33428
      • Neurology Offices of South Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Boca Raton, Florida, United States, 33487
      • South Florida Neurology Associates, P.A.
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • Gainesville, Florida, United States, 32607
      • UF Center for Movement Disorders and Neurorestoration
    • Hialeah, Florida, United States, 33016
      • Galiz Research
    • Kissimmee, Florida, United States, 34759
      • SIH Research
    • Maitland, Florida, United States, 32751
      • Neurology Associates
    • Miami, Florida, United States, 33122
      • Future Clinical Research
    • Miami, Florida, United States, 33174
      • Florida Research Center
    • Miami, Florida, United States, 33186
      • Novel Clinical Research Center, LLC
    • Miami, Florida, United States, 33125
      • Project 4 Research
    • Miami, Florida, United States, 33126
      • Premium Medical Research, Corp
    • Miami, Florida, United States, 33136
      • University Of Miami - Jackson Memorial Hospital, Dept. of Neurology
    • Miami, Florida, United States, 33155
      • Coral Way Research
    • Miami, Florida, United States, 33176
      • Anchor Medical Research, Llc
    • Miami Gardens, Florida, United States, 33014
      • Pro-Care Research Center, Corporation
    • Miami Lakes, Florida, United States, 33014
      • New Life Medical Research Center
    • Port Charlotte, Florida, United States, 33952
      • Neurostudies, Inc.
    • Port Charlotte, Florida, United States, 33952
      • Parkinson's Disease Treatment Center of Southwest Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida
    • Tampa, Florida, United States, 33604
      • Eminance Medical & Clinical Research
    • Tampa, Florida, United States, 33613
      • USF Parkinson's & Movement Disorders Center
    • Vero Beach, Florida, United States, 32960
      • Vero Neurology
    • Vero Beach, Florida, United States, 32962
      • Geodyssey Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Gainesville, Georgia, United States, 30501
      • Neurological Center of North Georgia
    • Gainesville, Georgia, United States, 30501
      • The Neurological Center of North Georgia
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
    • Chicago, Illinois, United States, 60612
      • Cardio Specialists Group, Ltd., Rush University Medical Center
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center - Department Of Cardiology
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center, Department of Neurology
    • Glenview, Illinois, United States, 60026
      • NorthShore Neurological Institute
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
    • Winfield, Illinois, United States, 60190
      • Northwestern Medicine Central DuPage Hospital
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Physician Network Indiana Heart Physicians
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
    • Kansas City, Kansas, United States, 66160
      • Mid America Cardiology - University of Kansas
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Louisiana Heart Center
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners Technology
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Mir Neurology
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital - Movement Disorders Clinic
    • Boston, Massachusetts, United States, 02114
      • Movement Disorders Clinic
    • Boston, Massachusetts, United States, 02130
      • Autonomic and Movement Disorders
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Faulkner Hospital (BWFH) - Brigham & Women's Foot & Ankle Center
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University, Department of Neurology
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Center of Medical Research
    • Farmington Hills, Michigan, United States, 48334
      • Detroit Clinical Research Center
    • Traverse City, Michigan, United States, 49684
      • Northern Michigan Neurology
    • Traverse City, Michigan, United States, 49684
      • Nothern Michigan Neurology
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford West Bloomfield Hospital
  • Nebraska
    • Kearney, Nebraska, United States, 68845
      • Platte Valley Medical Group
    • Omaha, Nebraska, United States, 68198
      • The Nebraska Medical Center
    • Omaha, Nebraska, United States, 68114
      • Methodist Physicians Clinic - Heart Consultants
    • Omaha, Nebraska, United States, 68114
      • MPC Heart Consultants
    • Omaha, Nebraska, United States, 68198-8435
      • University of Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Edison, New Jersey, United States, 08220
      • JFK Neuroscience Institution
    • Toms River, New Jersey, United States, 08755
      • Neuroscience Research Institute, LLC
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center
    • Commack, New York, United States, 11725
      • David L. Kreitzman MD, PC
    • Commack, New York, United States, 11725
      • Office of David L. Kreitzman, M.D., P.C.
    • Hawthorne, New York, United States, 10532
      • Neurology Associates of West Chester
    • New Hyde Park, New York, United States, 11040
      • Parker Jewish Institute for Health Care & Rehabilitation
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10021
      • Weill Cornell Medical College, Dept. of Neurology
    • New York, New York, United States, 10029
      • The Bendheim Parkinson and Movement Disorders Center
    • New York, New York, United States, 10032
      • Project 4 Research, Inc., The Neurological Institute at Columbia University Medical Center
    • New York, New York, United States, 10032
      • The Neurological Institute at Columbia University Medical Center
    • New York, New York, United States, 11542
      • Parker Jewish Institute For Healthcare And Rehabilitation
    • Plainview, New York, United States, 11803
      • Island Neurological Associates
    • Staten Island, New York, United States, 10306
      • Alpha Neurology
    • West Haverstraw, New York, United States, 10093
      • Helen Hayes Hospital
    • Williamsville, New York, United States, 14221
      • UBMD Neurology
  • North Carolina
    • Apex, North Carolina, United States, 27502
      • Peak Clinical Trials
    • Charlotte, North Carolina, United States, 28207
      • Carolinas HealthCare System Neurosciences Institute
    • Charlotte, North Carolina, United States, 28204
      • The Neurological Institute, PA
    • Charlotte, North Carolina, United States, 28205
      • Neurosciences Institute
  • Ohio
    • Bellevue, Ohio, United States, 44811
      • Insight Neuroscience, LLC
    • Centerville, Ohio, United States, 45459
      • Dayton center for neurological disorders
    • Cincinnati, Ohio, United States, 45219
      • Riverhills Healthcare, Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic - Taussig Cancer Institute
    • Columbus, Ohio, United States, 43221
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
    • Columbus, Ohio, United States, 43221
      • Ohio State University, Department of Neurology
    • Toledo, Ohio, United States, 43614
      • Medical College of Ohio, Department of Neurology
    • Toledo, Ohio, United States, 43614
      • Gardner-McMaster Parkinson Center - The University of Toledo
  • Oklahoma
    • Ardmore, Oklahoma, United States, 73401
      • Baha Abu-Esheh, MD
    • Ardmore, Oklahoma, United States, 73401
      • CardioVoyage, LLC
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • The Oregon Clinic
    • Portland, Oregon, United States, 97210
      • Legacy / Oregon Clinic Neurology
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • St. Luke's Neurology Associates
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Hershey, Pennsylvania, United States, 17025
      • Penn State Hershey Children's Hospital
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel Neurosciences Institute
    • Philadelphia, Pennsylvania, United States, 19107
      • University of Pennsylvania, Parkinson's Disease & Movement Disorders Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, Department of Neurology
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02903
      • Dr. Umer Akbar MD, Office of
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Autonomic Dysfunction Center - Clinical Trials Center
  • Texas
    • Carrollton, Texas, United States, 75006
      • iMD Medical Center
    • Carrollton, Texas, United States, 75006
      • Sunbeam Clinical Research
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Greenville, Texas, United States, 75401
      • Elite Primary Care
    • Greenville, Texas, United States, 75401
      • Sunbeam Clinical Research
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • McKinney, Texas, United States, 75069
      • Texas Institute of Cardiology, The Heartbeat Clinic
    • McKinney, Texas, United States, 75069
      • The Heartbeat Clinic
    • Prosper, Texas, United States, 75078
      • Sunbeam Clinical Research, LLC.
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
    • Tyler, Texas, United States, 75701
      • Christus Research Institute
    • Webster, Texas, United States, 77598
      • Clear Lake Specialties
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Bateman Home Center
  • Virginia
    • Alexandria, Virginia, United States, 22311
      • Inova Health Systems
    • Falls Church, Virginia, United States, 22043
      • Integrated Neurology Services, PLLC
    • Norfolk, Virginia, United States, 23507
      • Sentara Neurology Specialists
    • Norfolk, Virginia, United States, 23502
      • Health Research of Hampton Roads-Norfolk, Inc
    • Richmond, Virginia, United States, 23226
      • Henrico Doctors Neurology Associates, LLC
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic
  • Washington
    • Kirkland, Washington, United States, 98034
      • Booth Gardner Parkinson's Care Center
    • Spokane, Washington, United States, 99202
      • Northwest Neurology, Premier Clinical Research
    • Spokane, Washington, United States, 99202
      • Premeir Clinical Research
  • Wisconsin
    • Grafton, Wisconsin, United States, 53024
      • Aurora Medical Center
    • Grafton, Wisconsin, United States, 53024
      • Grafton Medical Office
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin, Department of Neurology
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Sinai Medical Center-Arrhythmia Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

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

Exclusion Criteria:

• 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

Additional protocol defined exclusion criteria do apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label Period; 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).	Drug: Droxidopa capsules; 100, 200 or 300 mg; Other Names: Northera
Placebo Comparator: Randomized Period; 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.	Drug: Placebo capsules; Other Names: Placebo; Drug: Droxidopa capsules; 100, 200 or 300 mg; Other Names: Northera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomization (Day 0) up to Week 12
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.	Randomization (Day 0) up to Week 12
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.	Randomization (Day 0); Weeks 2 to 12
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.	Randomization (Day 0); Weeks 2 to 12
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).	Weeks 2 to 12
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).	Weeks 2 to 12

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2016
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimated): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Multiple System Atrophy; Pure Autonomic Failure; Primary Autonomic Failure; Dopamine Beta Hydroxylase Deficiency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic; Antiparkinson Agents; Anti-Dyskinesia Agents; Droxidopa
• Other Study ID Numbers: 16306A; NOH402 (Other Identifier: NOH402)