Recruiting
Phase 2

L-DOPS

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT03567447

Conditions

Parkinson Disease

Falls Patient

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Droxidopa

Placebo

Study Details

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.

Conditions

Parkinson Disease

Falls Patient

Study ID

NCT03567447

Start date

Aug 17, 2018

Status verified date

Oct, 2019

Completion date

Mar 1, 2020

Anticipated

Primary completion date

Dec 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: Non treatment group

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.

Interventions

Droxidopa

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.

Placebo

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

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

Central Contacts and Locations

Central contacts

Margaret McCauley

602-406-8134Margaret.McCauley@dignityhealth.org

Pam Dewey

602-406-8252pam.dewey@dignityhealth.org

Locations

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

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Margaret McCauley, RN

602-406-8134

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Oct 29, 2019

Last verified

Oct, 2019

Keywords

  • Parkinsons Disease
  • PD
  • Patient Falls
  • Neurogenic Orthostatic Hypotension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2019-10-29.