search
Back to results

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

Primary Purpose

Parkinson Disease, Fatigue, Parkinsonism

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Northera
Placebo Oral Tablet
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cooper University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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).

Dosing regimen identical to active group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Epworth Sleepiness Scale
a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep

Full Information

First Posted
January 25, 2017
Last Updated
November 15, 2021
Sponsor
The Cooper Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT03034564
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Site staffing
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Fatigue, Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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).
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Dosing regimen identical to active group
Intervention Type
Drug
Intervention Name(s)
Northera
Other Intervention Name(s)
Droxidopa
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Parkinson's Disease Fatigue Scale
Description
16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
PDQ-39
Description
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
Time Frame
Week 12
Title
Epworth Sleepiness Scale
Description
a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew McGarry, MD
Organizational Affiliation
Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs