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

Primary Purpose

Orthostatic Intolerance, Parkinson's Disease

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Midodrine

About this trial

This is an interventional treatment trial for Orthostatic Intolerance

Eligibility Criteria

22 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with a diagnosis of idiopathic Parkinson's Disease
Those patients with measured orthostatic hypotension will be included in the positive control group
Those patients without measurable orthostatic hypotension who have symptoms of lightheadedness on standing will be included in the study group

Exclusion Criteria:

Diagnosis of degenerative parkinsonian syndromes other than idiopathic Parkinson's Disease
Inability to stand independently and remain standing for 5 minutes
Cognitive impairment that is significant enough to affect the ability of the patient to provide informed consent or to reliably report orthostatic symptoms
Patients with a pacemaker will also be excluded because the study is measuring heart rate responses which could potentially be altered by a pacemaker
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
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
Current treatment with other drugs for orthostatic hypotension such as fludrocortisone
Patients on phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, dihydroergotamine
Patients with acute or chronic renal failure (GFR <60)
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)
Pregnant or breast-feeding women.
Women of childbearing potential with no effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
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).
Patients with known drug allergy or hypersensitive to midodrine.

Sites / Locations

PVAMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Midodrine

Arm Description

Placebo given three times a day for 2 weeks

Midodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week

Outcomes

Primary Outcome Measures

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

improvement in symptoms of lightheadedness when standing

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02365012

First Posted

February 10, 2015

Last Updated

August 25, 2015

Sponsor

Corporal Michael J. Crescenz VA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02365012

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Corporal Michael J. Crescenz VA Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthostatic Intolerance, Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo given three times a day for 2 weeks

Arm Title

Midodrine

Arm Type

Active Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Midodrine

Intervention Description

Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance

Primary Outcome Measure Information:

Title

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

Description

improvement in symptoms of lightheadedness when standing

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a diagnosis of idiopathic Parkinson's Disease Those patients with measured orthostatic hypotension will be included in the positive control group Those patients without measurable orthostatic hypotension who have symptoms of lightheadedness on standing will be included in the study group Exclusion Criteria: Diagnosis of degenerative parkinsonian syndromes other than idiopathic Parkinson's Disease Inability to stand independently and remain standing for 5 minutes Cognitive impairment that is significant enough to affect the ability of the patient to provide informed consent or to reliably report orthostatic symptoms Patients with a pacemaker will also be excluded because the study is measuring heart rate responses which could potentially be altered by a pacemaker 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 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 Current treatment with other drugs for orthostatic hypotension such as fludrocortisone Patients on phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, dihydroergotamine Patients with acute or chronic renal failure (GFR <60) 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) Pregnant or breast-feeding women. Women of childbearing potential with no effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. 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). Patients with known drug allergy or hypersensitive to midodrine.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James Morley, MD/Ph.D.

Phone

215-823-5934

First Name & Middle Initial & Last Name or Official Title & Degree

Stephanie Wood

Phone

215-823-5934

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Morley, DOMD/Ph.D.

Organizational Affiliation

PVAMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

PVAMC

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James Morley, MD/Ph.D.

Phone

215-823-5934

12. IPD Sharing Statement

Learn more about this trial

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

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