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

NCT03034564 | Terminated Phase 4

• 1 other identifier: 16-159
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PDQ-39

  Week 12

• Epworth Sleepiness Scale

  Week 12

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

Dosing regimen identical to active group

Drug: Placebo Oral Tablet

Interventions

Northera DRUG

Also known as: Droxidopa

1

Placebo Oral Tablet DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Health System

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue; Parkinsonian Disorders

Interventions

Droxidopa

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norepinephrine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew McGarry, MD

  Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

US (1)