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

Sponsor
The Cooper Health System (Other)
Overall Status
Terminated
CT.gov ID
NCT03034564
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
20.9
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1 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 :
Jan 1, 2017
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

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 Names:
  • Droxidopa

    		•
    Placebo Comparator: 2

    Dosing regimen identical to active group

    Drug: Placebo Oral Tablet

    Outcome Measures

    Primary Outcome Measures

    1. Parkinson's Disease Fatigue Scale [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 [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 [Week 12]

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

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cooper University Health System Camden New Jersey United States 08103

    Sponsors and Collaborators

    • The Cooper Health System

    Investigators

    • Principal Investigator: Andrew McGarry, MD, Cooper Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Cooper Health System
    ClinicalTrials.gov Identifier:
    NCT03034564
    Other Study ID Numbers:
    • 16-159
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Parkinson Disease
    Parkinsonian Disorders
    Fatigue
    Droxidopa

    Study Results

    No Results Posted as of Nov 23, 2021