Orthostatic; Hypotension, NeurogenicPhase 4NCT02308124

Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

A Phase 4 study testing Midodrine, Pyridostigmine Bromide and Midodrine + pyridostigmine in people with Orthostatic; Hypotension, Neurogenic, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Orthostatic; Hypotension, Neurogenic
What is being tested?: Midodrine, Pyridostigmine Bromide and Midodrine + pyridostigmine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteSouth Korea
Study dates: Nov 2014to Sep 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

age >=18 patients who complained of dizziness
Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10

Who cannot join

Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
Heart failure or Chronic renal failure
Patients who cannot or do not want to write questionaires.
Poor drug compliance

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

Read the detailed description

In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.

Conditions: Orthostatic; Hypotension, Neurogenic
Being tested: Midodrine, Pyridostigmine Bromide, Midodrine + pyridostigmine
Medical subject headings: Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MidodrineDrug
Also called Midodrine only
Pyridostigmine BromideDrug
Also called Pyridostigmine only
Midodrine + pyridostigmineDrug
Also called Combination

Study groups in NCT02308124
Study group	Role	What they receive
Midodrine	Experimental	Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary. Receives: Drug: Midodrine
Pyridostigmine	Experimental	Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary. Receives: Drug: Pyridostigmine Bromide
Midodrine + Pyridostigmine	Experimental	Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary. Receives: Drug: Midodrine + pyridostigmine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Orthostatic BP Drop
Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.
Measured: after 3-month medical treatment

Secondary outcomes (4)

Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).
Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.
OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.
** OHQ total score minimal 0 ~ maximal 100
Measured: after 3-month medical treatment.
Change of the Depression Score (Beck Depression Inventory-II )
Change of the depression score after 3-month medical treatment compared to initial results.
21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.
Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63
Measured: after 3-month medical treatment.
Short-form 36 Version 2
changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline
SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.
Measured: changes at 3 months after treatment
Changes in Health-related Quality of Life
changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)
SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores.
Measured: changes at 3 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Sep 2016

First posted4 Dec 2014 (estimated)
Study startNov 2014
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Orthostatic; Hypotension, NeurogenicStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02308124
Sponsor's protocol ID: 1409066609
Status last verified: Sep 2021
First submitted: 2 Dec 2014
Last updated: 19 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Arbique D, Cheek D, Welliver M, Vongpatanasin W. Management of neurogenic orthostatic hypotension. J Am Med Dir Assoc. 2014 Apr;15(4):234-9. doi: 10.1016/j.jamda.2013.10.014. Epub 2014 Jan 2.
PubMed 24388946
Smith ND. Orthostatic Hypotension in the Patient with Diabetes: A Broad Review of Pharmacologic Treatment Options. Journal of Pharmacy Technology. 2013 January 1, 2013;29(1):23-34.
Low PA, Singer W. Management of neurogenic orthostatic hypotension: an update. Lancet Neurol. 2008 May;7(5):451-8. doi: 10.1016/S1474-4422(08)70088-7.
PubMed 18420158
Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.
PubMed 17976425
Goldstein DS, Sharabi Y. Neurogenic orthostatic hypotension: a pathophysiological approach. Circulation. 2009 Jan 6;119(1):139-46. doi: 10.1161/CIRCULATIONAHA.108.805887. No abstract available.
PubMed 19124673
Lahrmann H, Cortelli P, Hilz M, Mathias CJ, Struhal W, Tassinari M. EFNS guidelines on the diagnosis and management of orthostatic hypotension. Eur J Neurol. 2006 Sep;13(9):930-6. doi: 10.1111/j.1468-1331.2006.01512.x.
PubMed 16930356
Parsaik AK, Singh B, Altayar O, Mascarenhas SS, Singh SK, Erwin PJ, Murad MH. Midodrine for orthostatic hypotension: a systematic review and meta-analysis of clinical trials. J Gen Intern Med. 2013 Nov;28(11):1496-503. doi: 10.1007/s11606-013-2520-3. Epub 2013 Jun 18.
PubMed 23775146
Wright RA, Kaufmann HC, Perera R, Opfer-Gehrking TL, McElligott MA, Sheng KN, Low PA. A double-blind, dose-response study of midodrine in neurogenic orthostatic hypotension. Neurology. 1998 Jul;51(1):120-4. doi: 10.1212/wnl.51.1.120.
PubMed 9674789
Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012 Apr;22(2):79-90. doi: 10.1007/s10286-011-0146-2. Epub 2011 Nov 2.
PubMed 22045363
Jankovic J, Gilden JL, Hiner BC, Kaufmann H, Brown DC, Coghlan CH, Rubin M, Fouad-Tarazi FM; New Collective Author. Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. Am J Med. 1993 Jul;95(1):38-48. doi: 10.1016/0002-9343(93)90230-m.
PubMed 7687093
Low PA, Gilden JL, Freeman R, Sheng KN, McElligott MA. Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. JAMA. 1997 Apr 2;277(13):1046-51.
PubMed 9091692
Singer W, Opfer-Gehrking TL, McPhee BR, Hilz MJ, Bharucha AE, Low PA. Acetylcholinesterase inhibition: a novel approach in the treatment of neurogenic orthostatic hypotension. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1294-8. doi: 10.1136/jnnp.74.9.1294.
PubMed 12933939
Singer W, Sandroni P, Opfer-Gehrking TL, Suarez GA, Klein CM, Hines S, O'Brien PC, Slezak J, Low PA. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8. doi: 10.1001/archneur.63.4.noc50340. Epub 2006 Feb 13.
PubMed 16476804
Byun JI, Moon J, Kim DY, Shin H, Sunwoo JS, Lim JA, Kim TJ, Lee WJ, Lee HS, Jun JS, Park KI, Lee ST, Jung KH, Jung KY, Lee SK, Chu K. Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension. Neurology. 2017 Sep 5;89(10):1078-1086. doi: 10.1212/WNL.0000000000004340. Epub 2017 Aug 9.
PubMed 28794253

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Use of Accelerometer for Quantification of Neurogenic Orthostatic Hypotension Symptoms
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All Orthostatic; Hypotension, Neurogenic trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
ClinicalTrials.gov ID: NCT02308124
Acronym / sponsor ID: 1409066609
Conditions: Orthostatic; Hypotension, Neurogenic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Nov 2014
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 4 Dec 2014 (estimated)
Results: Posted 17 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Midodrine	Experimental	Drug: MidodrineStart midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
Pyridostigmine	Experimental	Drug: Pyridostigmine BromideStart Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
Midodrine + Pyridostigmine	Experimental	Drug: Midodrine + pyridostigmineStart midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

age >=18 patients who complained of dizziness
Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10

Key exclusion criteria (4 listed)

Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
Heart failure or Chronic renal failure
Patients who cannot or do not want to write questionaires.
Poor drug compliance

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
MidodrineAlso: Midodrine only	Drug	Midodrine
Pyridostigmine BromideAlso: Pyridostigmine only	Drug	Pyridostigmine
Midodrine + pyridostigmineAlso: Combination	Drug	Midodrine + Pyridostigmine

Primary outcome

Change in Orthostatic BP Drop
Time frame: after 3-month medical treatment
Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.

4 secondary outcomes

Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).
Time frame: after 3-month medical treatment.
Change of the Depression Score (Beck Depression Inventory-II )
Time frame: after 3-month medical treatment.
Short-form 36 Version 2
Time frame: changes at 3 months after treatment
Changes in Health-related Quality of Life
Time frame: changes at 3 months after treatment

Results and safety

Results posted to the registry on 17 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Midodrine Only	29	23
Pyridostigmine Only	29	21
Midodrine + Pyridostigmine	29	21

Primary outcome: Change in Orthostatic BP Drop

Time frame: after 3-month medical treatment. Mean (Standard Deviation). Unit: mmHg

Measure	Midodrine Only n = 23	Pyridostigmine Only n = 21	Midodrine + Pyridostigmine n = 21
Changes in SBP drop	11.1 (16.9)	13.6 (20.1)	8.9 (9.9)
Changes in DBP drop	7.5 (15.3)	11.1 (17.7)	7.4 (14.2)

Population analysed: At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Possible side effects were checked by direct questioning at each visit at 1 and 3 months after treatment. Expected adverse reactions were listed in the protocol.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Midodrine Only	0 of 29 (0%)	1 of 29 (3.4%)	Not reported
Pyridostigmine Only	0 of 29 (0%)	6 of 29 (20.7%)	Not reported
Midodrine + Pyridostigmine	0 of 29 (0%)	3 of 29 (10.3%)	Not reported

Limitations and caveats (from the sponsor): This study lacked a placebo group and a blinding process Compared with previous studies, which focused on primary autonomic degenerative disorders, our study included more patients with peripheral autonomic neuropathy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24388946Arbique D, Cheek D, Welliver M, Vongpatanasin W. Management of neurogenic orthostatic hypotension. J Am Med Dir Assoc. 2014 Apr;15(4):234-9. doi: 10.1016/j.jamda.2013.10.014. Epub 2014 Jan 2.
BackgroundSmith ND. Orthostatic Hypotension in the Patient with Diabetes: A Broad Review of Pharmacologic Treatment Options. Journal of Pharmacy Technology. 2013 January 1, 2013;29(1):23-34.
Background: PubMed 18420158Low PA, Singer W. Management of neurogenic orthostatic hypotension: an update. Lancet Neurol. 2008 May;7(5):451-8. doi: 10.1016/S1474-4422(08)70088-7.
Background: PubMed 17976425Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.
Background: PubMed 19124673Goldstein DS, Sharabi Y. Neurogenic orthostatic hypotension: a pathophysiological approach. Circulation. 2009 Jan 6;119(1):139-46. doi: 10.1161/CIRCULATIONAHA.108.805887. No abstract available.
Background: PubMed 16930356Lahrmann H, Cortelli P, Hilz M, Mathias CJ, Struhal W, Tassinari M. EFNS guidelines on the diagnosis and management of orthostatic hypotension. Eur J Neurol. 2006 Sep;13(9):930-6. doi: 10.1111/j.1468-1331.2006.01512.x.
Background: PubMed 23775146Parsaik AK, Singh B, Altayar O, Mascarenhas SS, Singh SK, Erwin PJ, Murad MH. Midodrine for orthostatic hypotension: a systematic review and meta-analysis of clinical trials. J Gen Intern Med. 2013 Nov;28(11):1496-503. doi: 10.1007/s11606-013-2520-3. Epub 2013 Jun 18.
Background: PubMed 9674789Wright RA, Kaufmann HC, Perera R, Opfer-Gehrking TL, McElligott MA, Sheng KN, Low PA. A double-blind, dose-response study of midodrine in neurogenic orthostatic hypotension. Neurology. 1998 Jul;51(1):120-4. doi: 10.1212/wnl.51.1.120.
Background: PubMed 22045363Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012 Apr;22(2):79-90. doi: 10.1007/s10286-011-0146-2. Epub 2011 Nov 2.
Background: PubMed 7687093Jankovic J, Gilden JL, Hiner BC, Kaufmann H, Brown DC, Coghlan CH, Rubin M, Fouad-Tarazi FM; New Collective Author. Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. Am J Med. 1993 Jul;95(1):38-48. doi: 10.1016/0002-9343(93)90230-m.
Background: PubMed 9091692Low PA, Gilden JL, Freeman R, Sheng KN, McElligott MA. Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. JAMA. 1997 Apr 2;277(13):1046-51.
Background: PubMed 12933939Singer W, Opfer-Gehrking TL, McPhee BR, Hilz MJ, Bharucha AE, Low PA. Acetylcholinesterase inhibition: a novel approach in the treatment of neurogenic orthostatic hypotension. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1294-8. doi: 10.1136/jnnp.74.9.1294.

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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.

Kon Chu principal investigator

Seoul National University Hospital, Seoul, South Korea

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 2021. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Orthostatic BP Drop (time frame: after 3-month medical treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02308124, which also lists 14 linked publications.

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 19 Oct 2021.