Treatment of Orthostatic Intolerance in Patients With Parkinson’s Disease Using Midodrine

Brief Title

Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine

Official Title

Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine

Brief Summary

      This study will evaluate whether treatment with the α1-agonist, midodrine, reduces subjective
      orthostatic lightheadedness as measured by the Non-Motor Symptoms Scale for Parkinson's
      Disease (NMSS) questionnaire, in patients with (positive control group, OH) or without
      documented orthostatic hypotension(orthostatic intolerance, OI). It will also demonstrate the
      effect of treatment with an α1-agonist, midodrine, on beat-to-beat blood pressure and heart
      rate response during Valsalva maneuver (measured by Continuous Non-invasive Arterial
      Pressure, CNAP) in patients with OI or OH and evaluate the relationship to symptom
      improvement.
    

Detailed Description

      This will be a cross-over study where participants with OI will be randomized to initially
      receive midodrine or placebo then crossed over to the opposite treatment after three weeks (2
      weeks on midodrine or placebo plus one week wash out period). The control group will consist
      of participants with OH and PD being treated with midodrine. Basic demographic data including
      will be collected from the medical record of each participant after consent. At each study
      visit, each participant will undergo traditional measurement of blood pressure and heart rate
      as well as measurement of beat-to-beat blood pressure and heart rate using CNAP™ during
      valsalva maneuver and in response to standing for 5 minutes after sitting. Symptoms of
      orthostatic intolerance will be measured during the study visit using Domain 1 of the
      Non-Motor Symptoms Scale for Parkinson's Disease (NMSS). At the initial study visit,
      participants will also be administered first dose of midodrine or placebo. Supine sitting,
      and standing systolic and diastolic blood pressure and pulse rates will be measured
      immediately before and 1 hour after the administration of drug or placebo. This blood
      pressure monitoring process will take place at each of the four study visits.
    


Study Type

Interventional


Primary Outcome

NMSS Domain I (improvement in symptoms of lightheadedness when standing)

Secondary Outcome

 Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver)

Condition

Orthostatic Intolerance

Intervention

Midodrine

Study Arms / Comparison Groups

 Placebo
Description:  Placebo given three times a day for 2 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

April 2014


Primary Completion Date

June 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with a diagnosis of idiopathic Parkinson's Disease

          2. Those patients with measured orthostatic hypotension will be included in the positive
             control group

          3. Those patients without measurable orthostatic hypotension who have symptoms of
             lightheadedness on standing will be included in the study group

        Exclusion Criteria:

          1. Diagnosis of degenerative parkinsonian syndromes other than idiopathic Parkinson's
             Disease

          2. Inability to stand independently and remain standing for 5 minutes

          3. Cognitive impairment that is significant enough to affect the ability of the patient
             to provide informed consent or to reliably report orthostatic symptoms

          4. Patients with a pacemaker will also be excluded because the study is measuring heart
             rate responses which could potentially be altered by a pacemaker

          5. Because this study will be using a drug that can affect blood pressure, those patients
             with a standing BP of > 139/90 and heart rate <60 will be excluded

          6. Because this study will be using a drug that can affect supine hypertension, those
             patients with a supine BP of >139/90 and heart rate <60 will be excluded

          7. Current treatment with other drugs for orthostatic hypotension such as fludrocortisone

          8. Patients on phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine,
             dihydroergotamine

          9. Patients with acute or chronic renal failure (GFR <60)

         10. Patients with a history of pheochromocytoma, urinary retention, severe cardiac
             disease, history of congestive heart failure, diabetes, narrow-angle glaucoma,
             arrhythmias, bradycardia, severe hyperthyroidism, severe difficult urination (due to
             urinary retention or enlarged prostate)

         11. Pregnant or breast-feeding women.

         12. Women of childbearing potential with no effective contraceptive method of birth
             control and/or who are unwilling or unable to be tested for pregnancy.

         13. Women of childbearing potential must have a confirmed negative pregnancy test at
             screening and randomization visits. They must use an effective contraceptive method
             throughout the study, and agree to repeat urine pregnancy test at designated visits.
             The applied methods of contraception have to meet the criteria for a highly effective
             method of birth control (condoms, FDA approved oral contraceptives, patches,
             injections, rings, IUD).

         14. Patients with known drug allergy or hypersensitive to midodrine.
      

Gender

All

Ages

22 Years - 89 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

James Morley, DOMD/Ph.D., 215-823-5934, 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02365012

Organization ID

01482


Responsible Party

Principal Investigator

Study Sponsor

Corporal Michael J. Crescenz VA Medical Center


Study Sponsor

James Morley, DOMD/Ph.D., Principal Investigator, PVAMC


Verification Date

August 2015