Clinical trial NCT03034564: A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parkinson Disease
Fatigue
Parkinsonism
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Parkinson's Disease Fatigue Scale
timeFrame: Week 12
Secondary outcomes:
measure: PDQ-39
timeFrame: Week 12
measure: Epworth Sleepiness Scale
timeFrame: Week 12
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Health System
state: New Jersey
Study officials:
affiliation: Cooper Health System
name: Andrew McGarry, MD
role: PRINCIPAL_INVESTIGATOR
References: