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

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ClinicalTrials.gov Identifier: NCT02365012
Recruitment Status : Unknown
Verified August 2015 by Stephanie Pawlowski Wood, Corporal Michael J. Crescenz VA Medical Center.
Recruitment status was:  Recruiting
First Posted : February 18, 2015
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Stephanie Pawlowski Wood, Corporal Michael J. Crescenz VA Medical Center

Tracking Information
First Submitted Date  ICMJE February 10, 2015
First Posted Date  ICMJE February 18, 2015
Last Update Posted Date August 26, 2015
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2015)
NMSS Domain I (improvement in symptoms of lightheadedness when standing) [ Time Frame: 7 weeks ]
improvement in symptoms of lightheadedness when standing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2015)
Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver) [ Time Frame: 7 weeks ]
Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Orthostatic Intolerance
  • Parkinson's Disease
Intervention  ICMJE Drug: Midodrine
Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo given three times a day for 2 weeks
  • Active Comparator: Midodrine
    Midodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week
    Intervention: Drug: Midodrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 17, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02365012
Other Study ID Numbers  ICMJE 01482
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephanie Pawlowski Wood, Corporal Michael J. Crescenz VA Medical Center
Study Sponsor  ICMJE Corporal Michael J. Crescenz VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Morley, DOMD/Ph.D. PVAMC
PRS Account Corporal Michael J. Crescenz VA Medical Center
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP