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Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension (RESTORE)

Primary Purpose

Symptomatic Neurogenic Orthostatic Hypotension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Droxidopa capsules
Placebo capsules
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Neurogenic Orthostatic Hypotension focused on measuring Parkinson's Disease, Multiple System Atrophy, Pure Autonomic Failure, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MDFirst Research - Chandler
  • 21st Century Neurology
  • Movement Disorders Center of Arizona
  • Center For Neurosciences
  • Movement Disorder Clinic - The University of Arizona
  • University of Arizona Health Sciences Center, Department Of Neurology
  • Arkansas Cardiology Clinic
  • East Bay Physicians Medical Group
  • Sutter East Bay Medical Foundation
  • The Parkinson's and Movement Disorder Institute
  • Behavioral Research Specialists, LLC
  • Loma Linda University Medical Center
  • University Of Southern California
  • Parkinson's Institute and Clinical Center
  • Diverse Research Solutions, LLC
  • Focilmed
  • Parkinsons Disease & Movement Disorder of Silicon Valley
  • Neurosearch, Inc. - Pasedena
  • Neurosearch, Inc. - Ventura
  • SC3 Research Group
  • Neurosearch, Inc. - Reseda
  • Radiological Associates of Sacramento
  • Sutter Neuroscience
  • The Parkinson's Institute and Clinical Center
  • Neurosearch Inc. - Torrance
  • Colorado Springs Neurological Associates
  • Associated Neurologists, P.C.
  • Associated Neurologists of Southern Connecticut, P.C.
  • Eastern Connecticut Neurology Specialists, LLC
  • Yale-New Haven Hospital
  • Yale Neurology / Hypertension Program
  • Yale University School Of Medicine
  • Christiana Care Neurology Specialists
  • Georgetown University
  • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
  • Neurology Offices Of South Florida
  • Parkinson's Disease And Movement Disorders Center of Boca Raton
  • South Florida Neurology Associates, P.A.
  • Innovative Research of West Florida
  • UF Center for Movement Disorders and Neurorestoration
  • Galiz Research
  • SIH Research
  • Neurology Associates
  • Pro-Care Research Center, Corporation
  • New Life Medical Research Center
  • Future Clinical Research
  • Project 4 Research
  • Premium Medical Research, Corp
  • University Of Miami - Jackson Memorial Hospital, Dept. of Neurology
  • Coral Way Research
  • Florida Research Center
  • Anchor Medical Research, LLC
  • Novel Clinical Research Center, LLC
  • Neurostudies, Inc.
  • Parkinson's Disease Treatment Center of Southwest Florida
  • Eminance Medical & Clinical Research
  • University Of South Florida
  • USF Parkinson's & Movement Disorders Center
  • Vero Neurology
  • Geodyssey Research, LLC
  • Emory University
  • Georgia Regents University
  • Neurological Center of North Georgia
  • The Neurological Center of North Georgia
  • Hawaii Pacific Neuroscience
  • Northwestern Medical Group
  • Cardio Specialists Group, Ltd., Rush University Medical Center
  • Rush University Medical Center - Department Of Cardiology
  • Rush University Medical Center, Department of Neurology
  • NorthShore Neurological Institute
  • Central Dupage Hospital
  • Northwestern Medicine Central DuPage Hospital
  • American Health Network of Indiana
  • Fort Wayne Neurological Center
  • Franciscan Physician Network Indiana Heart Physicians
  • Mid America Cardiology - University of Kansas
  • University of Kansas Medical Center
  • Louisiana Heart Center
  • Maine Medical Partners Technology
  • Mir Neurology
  • Tufts Medical Center
  • Massachusetts General Hospital - Movement Disorders Clinic
  • Movement Disorders Clinic
  • Autonomic and Movement Disorders
  • Brigham and Women's Faulkner Hospital (BWFH) - Brigham & Women's Foot & Ankle Center
  • Michigan State University, Department of Neurology
  • Detroit Clinical Research Center
  • Michigan Center of Medical Research
  • Northern Michigan Neurology
  • Nothern Michigan Neurology
  • Henry Ford West Bloomfield Hospital
  • Platte Valley Medical Group
  • Methodist Physicians Clinic - Heart Consultants
  • MPC Heart Consultants
  • University Of Nebraska Medical Center
  • The Nebraska Medical Center
  • Dartmouth-Hitchcock Medical Center
  • JFK Neuroscience Institution
  • Neuroscience Research Institute, LLC
  • SUNY Downstate Medical Center
  • David L. Kreitzman MD, PC
  • Office of David L. Kreitzman, M.D., P.C.
  • Neurology Associates of West Chester
  • Parker Jewish Institute for Health Care & Rehabilitation
  • Weill Cornell Medical College, Dept. of Neurology
  • The Bendheim Parkinson and Movement Disorders Center
  • Columbia University Medical Center
  • Project 4 Research, Inc., The Neurological Institute at Columbia University Medical Center
  • The Neurological Institute at Columbia University Medical Center
  • Parker Jewish Institute For Healthcare And Rehabilitation
  • Island Neurological Associates
  • Alpha Neurology
  • Helen Hayes Hospital
  • UBMD Neurology
  • Peak Clinical Trials
  • The Neurological Institute, PA
  • Neurosciences Institute
  • Carolinas HealthCare System Neurosciences Institute
  • Insight Neuroscience, LLC
  • Dayton Center for Neurological Disorders
  • Riverhills Healthcare, Inc.
  • Cleveland Clinic - Taussig Cancer Institute
  • Ohio Health Research Institute
  • Ohio State University, Department of Neurology
  • The Ohio State University
  • Gardner-McMaster Parkinson Center - The University of Toledo
  • Medical College of Ohio, Department of Neurology
  • Baha Abu-Esheh, MD
  • CardioVoyage, LLC
  • COR Clinical Research, LLC
  • Legacy / Oregon Clinic Neurology
  • The Oregon Clinic
  • St. Luke's Neurology Associates
  • Penn State Hershey Children's Hospital
  • Penn State Milton S. Hershey Medical Center
  • Drexel Neurosciences Institute
  • University of Pennsylvania, Parkinson's Disease & Movement Disorders Center
  • University of Pittsburgh, Department of Neurology
  • Dr. Umer Akbar MD, Office of
  • Rhode Island Hospital
  • Vanderbilt University Autonomic Dysfunction Center - Clinical Trials Center
  • iMD Medical Center
  • Sunbeam Clinical Research
  • UT Southwestern Medical Center
  • Elite Primary Care
  • Sunbeam Clinical Research
  • University of Texas Health Science Center at Houston
  • Texas Institute of Cardiology, The Heartbeat Clinic
  • The Heartbeat Clinic
  • Sunbeam Clinical Research, LLC.
  • Central Texas Neurology Consultants
  • Christus Research Institute
  • Clear Lake Specialties
  • Bateman Home Center
  • Inova Health Systems
  • Integrated Neurology Services, PLLC
  • Health Research of Hampton Roads-Norfolk, Inc
  • Sentara Neurology Specialists
  • Henrico Doctors Neurology Associates, LLC
  • Carilion Clinic
  • Booth Gardner Parkinson's Care Center
  • Northwest Neurology, Premier Clinical Research
  • Premeir Clinical Research
  • Aurora Medical Center
  • Grafton Medical Office
  • Aurora St. Luke's Medical Center
  • Medical College of Wisconsin, Department of Neurology
  • Aurora Sinai Medical Center-Arrhythmia Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Open Label Period

Randomized Period

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).

Full Information

First Posted
October 23, 2015
Last Updated
August 21, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02586623
Brief Title
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
Acronym
RESTORE
Official Title
RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2016 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Neurogenic Orthostatic Hypotension
Keywords
Parkinson's Disease, Multiple System Atrophy, Pure Autonomic Failure, Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label Period
Arm Type
Experimental
Arm Description
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).
Arm Title
Randomized Period
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Droxidopa capsules
Other Intervention Name(s)
Northera
Intervention Description
100, 200 or 300 mg
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time To Intervention
Description
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.
Time Frame
Randomization (Day 0) up to Week 12
Secondary Outcome Measure Information:
Title
Number of Participants Who Needed Intervention During the 12-week Double-Blind Treatment Period
Description
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.
Time Frame
Randomization (Day 0) up to Week 12
Title
Time To All-cause Discontinuation
Description
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.
Time Frame
Randomization (Day 0) up to Week 12
Title
Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Symptom Assessment (OHSA) Item #1 Score
Description
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.
Time Frame
Randomization (Day 0); Weeks 2 to 12
Title
Change From Randomization To All Post-randomization Visits in Orthostatic Hypotension Questionnaire (OHQ) Composite Score
Description
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.
Time Frame
Randomization (Day 0); Weeks 2 to 12
Title
Clinician-rated Clinical Global Impressions - Severity (CGI-S)
Description
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).
Time Frame
Weeks 2 to 12
Title
Participant-rated CGI-S
Description
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).
Time Frame
Weeks 2 to 12

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35107750
Citation
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.
Results Reference
derived

Learn more about this trial

Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

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