Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease

NCT03173781 | Completed DMC

• 1 other identifier: CSNA001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if droxidopa reduces fall risk by improving gait speed, kyphosis, and functional reach in individuals with Parkinson's disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Evaluate the efficacy of droxidopa when measuring walking speed using the 10 meter walk test .

  10 meter walk test * Subject walks without assistance 10 meters (32.8 feet). * Assistive devices can be used but should be kept consistent and documented from test to test. * If physical assistance is required to walk, this should not be performed * Collect three trials and calculate the average of the three trials * Individuals are permitted to use the assistive device they typically use in the community, but without the assistance of another person.

  24 months

• Evaluate the efficacy of droxidopa when measuring walking speed using Dual Task Timed Up and Go test

  * Subjects are given verbal instructions to stand up from a chair, walk 3 meters as quickly and safely as possible, cross a line marked on the floor, turn around, walk back, and sit down. * In the TUG (Cognitive), individuals were asked to complete the test while counting backward by threes from a randomly selected number between 20 and 100.

  24 months

Secondary Outcomes (2)

• Evaluate the efficacy of droxidopa when measuring degree of thoracic curvature using the Flexicurve rule

  24 months

• Evaluate the efficacy of droxidopa when measuring fall risk using the Forward Functional Reach test.

  24 months

Study Arms (2)

droxidopa

EXPERIMENTAL

Droxidopa will be supplied in 100 and 200 mg pill sizes. The subject should administer the three doses 4 hours apart with the last dose prior to 4:00 pm (example: 8:00 am, 12:00 pm, and 4:00 pm). The proposed dosing is 100mg TID at baseline, then titrate slowly up to 600 mg TID. During titration, droxidopa or placebo, initiated at 100 mg TID was titrated upward in 100-mg TID increments every 48 hours until the subject: 1. Reaches the maximum permitted dosage of 600 mg TID; 2. Has a systolic blood pressure≥160mmHg or diastolic blood pressure ≥100mmHg after 10 minutes supine on 3 consecutive measurements; or 3. Experiences intolerable adverse events (AEs).

Drug: droxidopa

placebo

PLACEBO COMPARATOR

sugar pill

Drug: Placebo

Interventions

droxidopa DRUG

medication

Also known as: Northera

droxidopa

Placebo DRUG

medication

Also known as: sugar pill

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Clinical diagnosis of Parkinson's disease.
• Stable dose of current Parkinson's disease medication(s) for the past 2 weeks.
• Stable deep brain stimulator settings for the past 2 weeks.
• Provide written informed consent to participate in the study.

You may not qualify if:

• Concomitant use of vasoconstricting agents for the purpose of increasing blood pressure.
• Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine must stop taking these drugs at least 2 days prior to baseline and throughout the duration of the study.
• Concomitant use of the following medications:
• Anti-hypertensive medication for the treatment of essential hypertension
• Vasoconstricting agents such as ephedrine, dihydroergotamine, or midodrine. Concomitant treatment for symptomatic NOH (with the exception of vasoconstricting agents) will be permitted during the study. This includes fludrocortisone, which is permitted during the study. Medications for the treatment of PD will be permitted during the study.
• Sumatriptan-like drugs, (for example, naratriptan, zolmitriptan, rizatriptan)
• Cyclopropane or halothane, or other halogen-containing inhalational anesthetics
• Catecholamine-containing preparations (e.g. isoprenaline)
• Non-selective monoamine oxidase inhibitors (MAOIs)
• Ergotamine derivatives (except if anti-Parkinsonian medication)
• Any investigational medication.
• Uncontrolled depression.
• Prior history of neuroleptic malignant syndrome.
• History of suicide attempt within the previous 2 years.
• Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse).

Sponsors & Collaborators

• Colorado Springs Neurological Associates: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Droxidopa; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Norepinephrine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Study Officials

• Christen Kutz, PhD, PA-C

  Colorado Springs Neurological Associates

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: June 2, 2017
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)