A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease

This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization. Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep. There will be a screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of informed consent, concomitant medication review, adverse event review, pill counts, vital signs (including supine blood pressure), and outcome measurements. Telephone visits will include review of informed consent, concomitant medication review, and adverse event review.

Study Overview

• Status: Terminated
• Conditions: Fatigue; Parkinson Disease; Parkinsonism
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Northera

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Parkinson's Disease
• Have normal kidney function (determined at screening visit by blood sample analysis), and no active medical diagnoses associated with fatigue
• No orthostatic symptoms (i.e. light headedness, blurred vision, and/or muscle weakness)
• No objective orthostasis (significant drop in blood pressure when standing)
• No supine hypertension (high blood pressure while laying down) judged to be of clinical significance by the investigator
• Well-controlled depression
• Stable dopaminergic medication regimen for 6 weeks prior to screening
• No concurrent use of fludrocortisone, midodrine, or other medications that may raise blood pressure
• PD Fatigue Scale Score of 50 or above

Exclusion Criteria:

• Diagnosis of Atypical Parkinsonism (having symptoms that mimic PD without a PD diagnosis)
• Prior Intolerance of droxidopa
• SNRI or TCA class (both antidepressant) medications (irrespective of indication)
• Use of activating agents (amantadine, modafinil, methylphenidate and related stimulants)
• Significant cardiac disease history
• Significant kidney disease history, or creatinine (a chemical found in the blood) greater than 1.5 mg/dl at baseline
• Poorly controlled depression
• Women who are pregnant or breastfeeding
• Significant history of Gastro Intestinal disease that may interfere with absorption (gastric bypass, inflammatory bowel disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Active group started 100 mg TID, increased by 100 mg per interval (i.e. 100 TID) every 2 days till on 600 TID, or until intolerable dose is achieved at which time the next highest dose will be maintained (increments of 100 TID will be used).	Drug: Northera; Other Names: Droxidopa
Placebo Comparator: 2; Dosing regimen identical to active group	Drug: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parkinson's Disease Fatigue Scale	16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDQ-39	a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being	Week 12
Epworth Sleepiness Scale	a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep	Week 12

Collaborators and Investigators

• Sponsor: The Cooper Health System
• Investigators: Principal Investigator: Andrew McGarry, MD, Cooper Health System

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Fatigue; Parkinson Disease; Parkinsonian Disorders; Antiparkinson Agents; Anti-Dyskinesia Agents; Droxidopa
• Other Study ID Numbers: 16-159