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

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ClinicalTrials.gov Identifier: NCT03173781
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Colorado Springs Neurological Associates

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: droxidopa Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Droxidopa When Measuring Gait Speed, Kyphosis, and Functional Reach in Parkinson's Disease
Study Start Date : April 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Droxidopa

Arm Intervention/treatment
Experimental: droxidopa

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
medication
Other Name: Northera

Placebo Comparator: placebo
sugar pill
Drug: Placebo
medication
Other Name: sugar pill




Primary Outcome Measures :
  1. Evaluate the efficacy of droxidopa when measuring walking speed using the 10 meter walk test . [ Time Frame: 24 months ]

    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.

  2. Evaluate the efficacy of droxidopa when measuring walking speed using Dual Task Timed Up and Go test [ Time Frame: 24 months ]
    • 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.


Secondary Outcome Measures :
  1. Evaluate the efficacy of droxidopa when measuring degree of thoracic curvature using the Flexicurve rule [ Time Frame: 24 months ]

    Flexi-curve measurement

    • Instruct subject to "stand in your usual best posture"
    • Identify C7 spinous process.
    • Identify the L-S interspace.
    • Mark each landmark (C7 process and L-S space) with a single horizontal grease pencil line.
    • Make sure the patient is standing in their usual best posture so that the marks are in the correct place during measurement using flexi-curve ruler.

  2. Evaluate the efficacy of droxidopa when measuring fall risk using the Forward Functional Reach test. [ Time Frame: 24 months ]

    Forward Functional Reach test

    • Using a yardstick mounted on the wall at shoulder height, ask the subject to position body close to, but not touching the wall with arm outstretched and hand fisted. Take note of the starting position by determining what number the MCP joints line up with on the rule.
    • Have the subject reach as far forward as possible in a plane parallel with the measuring device.
    • Instruct subject to "Reach as far forward as you can go without taking a step." Subjects are free to use various reaching strategies.
    • Take note of the end position of the MCP joints against the ruler, and record the difference between the starting and end position numbers.
    • If the feet move, that trial must be discarded and repeated.



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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:

Inclusion Criteria:

  1. 18 years of age or older.
  2. Clinical diagnosis of Parkinson's disease.
  3. Stable dose of current Parkinson's disease medication(s) for the past 2 weeks.
  4. Stable deep brain stimulator settings for the past 2 weeks.
  5. Provide written informed consent to participate in the study.

Exclusion Criteria:

  1. 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.

  2. Concomitant use of the following medications:
  3. Anti-hypertensive medication for the treatment of essential hypertension
  4. 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.
  5. Sumatriptan-like drugs, (for example, naratriptan, zolmitriptan, rizatriptan)
  6. Cyclopropane or halothane, or other halogen-containing inhalational anesthetics
  7. Catecholamine-containing preparations (e.g. isoprenaline)
  8. Non-selective monoamine oxidase inhibitors (MAOIs)
  9. Ergotamine derivatives (except if anti-Parkinsonian medication)
  10. Any investigational medication.
  11. Uncontrolled depression.
  12. Prior history of neuroleptic malignant syndrome.
  13. History of suicide attempt within the previous 2 years.
  14. Known or suspected alcohol or substance abuse within the past 12 months (DSM-IV definition of alcohol or substance abuse).
  15. Women who are pregnant or breastfeeding.
  16. Women of child bearing potential (WOCP) who are not using at least one method of contraception with their partner.
  17. Male patients who are sexually active with a woman of child bearing potential (WOCP) and not using at least one method of contraception.
  18. Untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the patient.
  19. Sustained severe hypertension (BP ≥ 180 mmHg systolic or ≥ 110 mmHg diastolic in the seated or supine position which is observed in 3 consecutive measurements over an hour).
  20. Any significant uncontrolled cardiac arrhythmia.
  21. History of myocardial infarction, within the past 2 years.
  22. Current unstable angina.
  23. Congestive heart failure (NYHA Class 3 or 4).
  24. Diabetic autonomic neuropathy.
  25. History of cancer within the past 2 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ.
  26. Gastrointestinal condition, which in the Investigator's judgment, may affect the absorption of study drug (e.g. ulcerative colitis, gastric bypass).
  27. Any major surgical procedure within 30 days of the baseline visit
  28. Previous or current treatment with droxidopa.
  29. Current participation in individual physical therapy, specifically for balance or gait.
  30. Any condition or laboratory test result, which in the Investigator's judgment, might result in an increased risk to the patient, or would affect their participation in the study.
  31. Additionally the Investigator has the ability to exclude a patient if for any reason they feel the subject is not a good candidate for the study or will not be able to follow study procedures.

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): NCT03173781


Locations
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United States, Colorado
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
Sponsors and Collaborators
Colorado Springs Neurological Associates
H. Lundbeck A/S
Investigators
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Study Director: Christen Kutz, PhD, PA-C Colorado Springs Neurological Associates
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Responsible Party: Colorado Springs Neurological Associates
ClinicalTrials.gov Identifier: NCT03173781    
Other Study ID Numbers: CSNA001
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: movement disorder meeting/poster/paper
Additional relevant MeSH terms:
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Kyphosis
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Droxidopa
Antiparkinson Agents
Anti-Dyskinesia Agents