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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fatigue, Parkinson Disease, Parkinsonism

Intervention / Treatment
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* Drug: Northera
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br> <br> * Other names: Droxidopa;|
| Placebo Comparator: 2<br>Dosing regimen identical to active group | Drug: Placebo Oral Tablet<br> <br> |

What is the study measuring?
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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 |