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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

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.

Condition or disease Intervention/treatment Phase
Orthostatic Intolerance Parkinson's Disease Drug: Midodrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
Study Start Date : April 2014
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Midodrine
Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance




Primary Outcome Measures :
  1. NMSS Domain I (improvement in symptoms of lightheadedness when standing) [ Time Frame: 7 weeks ]
    improvement in symptoms of lightheadedness when standing


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02365012


Contacts
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Contact: James Morley, MD/Ph.D. 215-823-5934
Contact: Stephanie Wood 215-823-5934

Locations
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United States, Pennsylvania
PVAMC Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: James Morley, MD/Ph.D.    215-823-5934      
Sponsors and Collaborators
Corporal Michael J. Crescenz VA Medical Center
Investigators
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Principal Investigator: James Morley, DOMD/Ph.D. PVAMC
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Responsible Party: Stephanie Pawlowski Wood, Research Administrator, Corporal Michael J. Crescenz VA Medical Center
ClinicalTrials.gov Identifier: NCT02365012    
Other Study ID Numbers: 01482
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Parkinson Disease
Orthostatic Intolerance
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Neurologic Manifestations
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action