NCT03567447

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 30 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease
• Falls Patient

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2018-08-17
• Primary completion: 2019-12-01
• Completion: 2020-03-01
• First posted: 2018-06-25
• Last updated: 2019-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study