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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colorado Springs Neurological Associates
• Collaborator: H. Lundbeck A/S
• Treatments: Droxidopa

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.