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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03567447
• Date of registration: 21/05/2018
• Prospective Registration: Yes
• Primary sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Public title: Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)
• Scientific title: Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)
• Date of first enrolment: August 17, 2018
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03567447
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Abraham Lieberman, MD
• Affiliation: Barrow Neurological Insitute

• Name: Margaret McCauley, RN

• Name: Margaret McCauley

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: 83 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Falls Patient

Intervention(s)

Other: Placebo

Drug: Droxidopa

Primary Outcome(s)

Change in number of falls [Time Frame: Study weeks 2, 4 and 8]

Secondary Outcome(s)

Change in objective and subjective measures of Balance [Time Frame: Study weeks 2, 4 and 8]

Secondary ID(s)

16-0200-80-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

H. Lundbeck A/S

Arizona State University