Effect of L-Dihydroxyphenylserine (L-DOPS) on Falls in Patients With Neurogenic Orthostatic Hypotension (NOH)
Parkinson Disease, Falls Patient
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
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
Sites / Locations
- Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Treatment group
Non treatment group
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.