Orthostatic IntoleranceNCT02365012
Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
A study testing Midodrine in people with Orthostatic Intolerance and Parkinson's Disease, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Intolerance, Parkinson's Disease
- What is being tested?
- Midodrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
James Morley, MD/Ph.D. contact
Stephanie Wood contact
United States1 site, 1 recruiting
- Recruiting
PVAMC
Philadelphia, Pennsylvania, 19104
James Morley, MD/Ph.D., 215-823-5934
About this study
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.
Read the 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.
- Conditions
- Orthostatic Intolerance, Parkinson's Disease
- Being tested
- Midodrine
- Medical subject headings
- Orthostatic Intolerance, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo given three times a day for 2 weeks |
| Midodrine | Active comparator | Midodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week Receives: Drug: Midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
NMSS Domain I (improvement in symptoms of lightheadedness when standing)
improvement in symptoms of lightheadedness when standing
Measured: 7 weeks
Secondary outcomes (1)
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
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stephanie Pawlowski Wood, Corporal Michael J. Crescenz VA Medical Center
- Investigators
- James Morley, DOMD/Ph.D., Principal investigator, PVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365012
- Sponsor's protocol ID
- 01482
- Status last verified
- Aug 2015
- First submitted
- 10 Feb 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
- ClinicalTrials.gov ID
- NCT02365012
- Acronym / sponsor ID
- 01482
- Conditions
- Orthostatic Intolerance, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Study start
- Apr 2014
- Primary completion
- Jun 2017 (estimated)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | –Placebo given three times a day for 2 weeks |
| Midodrine | Active comparator | Drug: MidodrineMidodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week |
Who may qualify
- Ages
- 22 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidodrineCrossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance | Drug | Midodrine |
Primary outcome
NMSS Domain I (improvement in symptoms of lightheadedness when standing)
Time frame: 7 weeks
improvement in symptoms of lightheadedness when standing
1 secondary outcome
Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver)
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Morley, MD/Ph.D. contact
Stephanie Wood contact
James Morley, DOMD/Ph.D. principal investigator
PVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine in people with Orthostatic Intolerance and Parkinson's Disease, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Morley, MD/Ph.D. (215-823-5934), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NMSS Domain I (improvement in symptoms of lightheadedness when standing) (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.