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

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ClinicalTrials.gov Identifier: NCT03034564
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Fatigue Parkinsonism Drug: Northera Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's Disease
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Droxidopa

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 Name: Droxidopa

Placebo Comparator: 2
Dosing regimen identical to active group
Drug: Placebo Oral Tablet



Primary Outcome Measures :
  1. Parkinson's Disease Fatigue Scale [ Time Frame: Week 12 ]
    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 Outcome Measures :
  1. PDQ-39 [ Time Frame: Week 12 ]
    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

  2. Epworth Sleepiness Scale [ Time Frame: Week 12 ]
    a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034564


Contacts
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Contact: Andrew March, BS 856-342-2460 march-andrew@cooperhealth.edu

Locations
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United States, New Jersey
Cooper University Health System Recruiting
Camden, New Jersey, United States, 08103
Contact: Andrew March, BS    856-342-2460    march-andrew@cooperhealth.edu   
Principal Investigator: Andrew McGarry, MD         
Sub-Investigator: Amy Colcher, MD         
Sponsors and Collaborators
The Cooper Health System
Investigators
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Principal Investigator: Andrew McGarry, MD Cooper Health System

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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT03034564     History of Changes
Other Study ID Numbers: 16-159
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Parkinson Disease
Fatigue
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms
Droxidopa
Antiparkinson Agents
Anti-Dyskinesia Agents