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

NCT ID: NCT03034564

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-09-30

Brief Summary

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.

Conditions

Parkinson Disease; Fatigue; Parkinsonism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Northera

Intervention Type: DRUG

2

Dosing regimen identical to active group

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Interventions

Northera

Intervention Type: DRUG

Placebo Oral Tablet

Intervention Type: DRUG

Other Intervention Names

Droxidopa

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew McGarry, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper Health System

Locations

Cooper University Health System

Camden, New Jersey, United States

Countries

United States

Other Identifiers

16-159

Identifier Type: -

Identifier Source: org_study_id