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Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)

Primary Purpose

Parkinson Disease, Falls Patient

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Droxidopa
Placebo
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinsons Disease, PD, Patient Falls, Neurogenic Orthostatic Hypotension

Eligibility Criteria

30 Years - 83 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
  2. Subject is male or female and is ≥ 30 and ≤ 83 years of age.
  3. Parkinson's diagnosis with history of falls or gait difficulty.
  4. Subject demonstrates neurogenic orthostatic hypotension (drop of 20 mm/Hg Systolic or 10 mm/Hg diastolic or both within 3 min of standing)
  5. Fell more than once in past year.
  6. Montreal Cognitive Assessment (MoCA) score ≥ 21.
  7. Stable dose of levodopa, dopamine agonist, amantadine, and/or monoamine oxidase B inhibitor, i.e. unchanged for 1 month.
  8. Subject is ambulatory and able to walk ≥ 10 meters with/without the use of an assistive device.

Exclusion Criteria:

  1. Subject has a clinical diagnosis of an atypical Parkinsonism
  2. Subject has a clinical diagnosis of PD that is suspicious to the investigator as being a possible case of atypical Parkinson's
  3. History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study; history of major depressive disorder in the past year, or current major depressive episode
  4. Patients with systolic BP ≤70 mm/hg
  5. Subjects with a history of coronary artery disease or congestive heart failure
  6. Participation in another investigational drug or device study in during the 60 days prior to the Screening Visit
  7. Treatment with any anti-hypertensive medications
  8. Treatment with any anti-spasmodic medications
  9. Treatment with medications intended to elevate blood pressure
  10. Treatment with non-specific monoamine oxidase (MAO) inhibitors

Sites / Locations

  • Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Non treatment group

Arm Description

This group will receive droxidopa 100mg to 600mg three times a day (TID) titration for 2 weeks and then maintenance dosage for 4 additional weeks. We will assess participants two times over the 4-week intervention. Each assessment will be the same as the baseline assessment, including the Orthostatic Hypotension Symptom Assessment (OHSA), postural, and gait assessments, and will be administered during the 2nd and 4th weeks following onset of stable treatment phase.

This group will receive placebo appearing to be 100mg to 600mg three times a day (TID) titration for 2 weeks and then maintenance dosage for 4 additional weeks. We will assess participants two times over the 4-week intervention. Each assessment will be the same as the baseline assessment, including the Orthostatic Hypotension Symptom Assessment (OHSA), postural, and gait assessments, and will be administered during the 2nd and 4th weeks following onset of stable treatment phase.

Outcomes

Primary Outcome Measures

Change in number of falls
The effect of L-DOPS on falls will be assessed by measuring the number of falls during balance perturbation testing.

Secondary Outcome Measures

Change in objective and subjective measures of Balance
The effect of L-DOPS on assessments of balance by Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Full Information

First Posted
May 21, 2018
Last Updated
October 25, 2019
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
H. Lundbeck A/S, Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT03567447
Brief Title
Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)
Official Title
Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
H. Lundbeck A/S, Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be a Phase II single center, double-blind, randomized, placebo-controlled, efficacy study. Subjects will complete six visits. The first will be a screening visit. There will be four assessment visits: baseline, 2 weeks after the double-blinded trial begins, the end of the blinded trial, and after 4 weeks of washout. There will also be an additional randomization and medication dispensing visit immediately following the dose optimization period and preceding the double-blinded trial.
Detailed Description
Injuries associated with falls continue to pose a significant burden to patients with Parkinson's disease (PD) both in terms of human suffering and economic losses. Overall annual fall incidence rates range from 50-70% for PD patients, and recurrent falls are a major cause of disability in PD. Approximately 20% of patients with Parkinson's disease develop NOH which can lead to falls. Although the mechanisms underlying impaired postural stability and falls are not well-known in patients with PD, attention is focused on the noradrenergic system. L-DOPS, a drug that enhances norepinephrine levels in peripheral and central nervous system, has been shown to moderate NOH, and often improve symptoms concomitant of PD and falls. This study will help to determine the effect of L-DOPS in reducing falls and fall severity by using an instrumented walkway to induce slip perturbations can assess the propensity for falls and fall-related outcomes. It will assess fall events from the point of initiation through recovery. The effect of L-DOPS on gait and balance parameters will also be measured using force plate and inertial measurement unit (IMU) testing, and improvement in clinical scores such as the MDS-UPDRS will be monitored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Falls Patient
Keywords
Parkinsons Disease, PD, Patient Falls, Neurogenic Orthostatic Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase II single center, double-blind, randomized, placebo-controlled, efficacy study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind masking
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
This group will receive droxidopa 100mg to 600mg three times a day (TID) titration for 2 weeks and then maintenance dosage for 4 additional weeks. We will assess participants two times over the 4-week intervention. Each assessment will be the same as the baseline assessment, including the Orthostatic Hypotension Symptom Assessment (OHSA), postural, and gait assessments, and will be administered during the 2nd and 4th weeks following onset of stable treatment phase.
Arm Title
Non treatment group
Arm Type
Placebo Comparator
Arm Description
This group will receive placebo appearing to be 100mg to 600mg three times a day (TID) titration for 2 weeks and then maintenance dosage for 4 additional weeks. We will assess participants two times over the 4-week intervention. Each assessment will be the same as the baseline assessment, including the Orthostatic Hypotension Symptom Assessment (OHSA), postural, and gait assessments, and will be administered during the 2nd and 4th weeks following onset of stable treatment phase.
Intervention Type
Drug
Intervention Name(s)
Droxidopa
Other Intervention Name(s)
NORTHERA
Intervention Description
starting with 100 mg TID and increasing in 100 mg TID increments, to a maximum of 600mg TID, to identify the highest tolerated dose for each patient.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
appearing to be 100 mg TID and increasing in 100 mg TID increments, to a maximum of 600mg TID, to identify the highest tolerated dose for each patient.
Primary Outcome Measure Information:
Title
Change in number of falls
Description
The effect of L-DOPS on falls will be assessed by measuring the number of falls during balance perturbation testing.
Time Frame
Study weeks 2, 4 and 8
Secondary Outcome Measure Information:
Title
Change in objective and subjective measures of Balance
Description
The effect of L-DOPS on assessments of balance by Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time Frame
Study weeks 2, 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study. Subject is male or female and is ≥ 30 and ≤ 83 years of age. Parkinson's diagnosis with history of falls or gait difficulty. Subject demonstrates neurogenic orthostatic hypotension (drop of 20 mm/Hg Systolic or 10 mm/Hg diastolic or both within 3 min of standing) Fell more than once in past year. Montreal Cognitive Assessment (MoCA) score ≥ 21. Stable dose of levodopa, dopamine agonist, amantadine, and/or monoamine oxidase B inhibitor, i.e. unchanged for 1 month. Subject is ambulatory and able to walk ≥ 10 meters with/without the use of an assistive device. Exclusion Criteria: Subject has a clinical diagnosis of an atypical Parkinsonism Subject has a clinical diagnosis of PD that is suspicious to the investigator as being a possible case of atypical Parkinson's History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study; history of major depressive disorder in the past year, or current major depressive episode Patients with systolic BP ≤70 mm/hg Subjects with a history of coronary artery disease or congestive heart failure Participation in another investigational drug or device study in during the 60 days prior to the Screening Visit Treatment with any anti-hypertensive medications Treatment with any anti-spasmodic medications Treatment with medications intended to elevate blood pressure Treatment with non-specific monoamine oxidase (MAO) inhibitors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret McCauley
Phone
602-406-8134
Email
Margaret.McCauley@dignityhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pam Dewey
Phone
602-406-8252
Email
pam.dewey@dignityhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Lieberman, MD
Organizational Affiliation
Barrow Neurological Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret McCauley, RN
Phone
602-406-8134

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)

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