Shy-Drager SyndromeEarly Phase 1NCT02149901
Water and Sudafed in Autonomic Failure
A Early Phase 1 study testing Pseudoephedrine + 480 ml water and Pseudoephedrine + 50 ml water in people with Shy-Drager Syndrome and Multiple System Atrophy, run by Vanderbilt University at 1 site in United States.
Trial summary
The specific aim of this study is to determine whether water ingestion potentiates the pressor response to pseudoephedrine in patients with primary disorders of autonomic failure. The study design will enable us to also evaluate the pressor response to water alone and to pseudoephedrine alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shy-Drager Syndrome, Multiple System Atrophy
- What is being tested?
- Pseudoephedrine + 480 ml water and Pseudoephedrine + 50 ml water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2020
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, with
- Neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing,
- Associated with impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase IV of the valsalva maneuver,
- Absence of other identifiable causes of autonomic neuropathy, and
- Able and willing to provide informed consent
Who cannot join
- Pregnancy
- Current smoking habit
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
- Known intolerance to pseudoephedrine
- Pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting position)
- Clinically unstable coronary artery disease or major cardiovascular or neurological event in the past 6 months.
Show all 11Show fewer
- Any other significant systemic, hepatic, cardiac or renal illness
- Use of MAO-I (i.e. selegiline; rasagiline - Azilect, linezolid and others) within 14 days
- Known closed-angle glaucoma
- Clinically meaningful arrhythmias
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure
The specific aim of this study is to determine whether water ingestion potentiates the pressor response to pseudoephedrine in patients with primary disorders of autonomic failure. The study design will enable us to also evaluate the pressor response to water alone and to pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater increase in blood pressure than pseudoephedrine alone.
Read the detailed description
The maximal pressor response to water is reached when other pressor agents are only beginning to act. In addition to the therapeutic value of water ingestion alone, the blood pressure-raising effects of agents that increase sympathetic nervous system tone, such as phenylpropanolamine, are potentiated by water drinking. These drug interaction effects can be exploited in the treatment of orthostatic hypotension with the combination of water and a sympathomimetic potentially able to increase blood pressure to a greater extent and for a longer period of time than either water or the medication alone. However, the interaction can also lead to potentially dangerous blood pressure surges.
This protocol requires an initial screening history and physical of study participants, including safety labs and EKGs, and evaluation of their autonomic nervous system status following the consent process. If the patient meets study criteria and is willing to undergo study testing, the 4-way crossover protocol will follow.
Study Testing days 1 and 2 Arm 1: Pseudoephedrine 30 mg PO + 50 ml water Arm 2: Pseudoephedrine 30 mg PO + 480 ml water
- Testing will be performed at the same time of day for all studies, at least 2 hours after a meal to avoid any confounding effects from postprandial hypotension.
- A saline lock will be inserted for blood sampling at least 30 minutes before baseline data collection.
- Participants will be asked to empty their bladders before beginning the test to avoid any effect of a full urinary bladder on peripheral sympathetic activity.
- Participants will be seated comfortably in a chair. They will be asked to remain in the seated position for the duration of the study.
- The Dinamap electrocardiographic and blood pressure (brachial cuff) recorder will be attached to the patient and set up for measurements every 5 minutes throughout the study with digital download into the ADC (Autonomic Dysfunction Center) BP database.
- Participants will also be instrumented with EKG, finger cuff and sensor for continuous monitoring of blood pressure, heart rate, respiration, SpO2, stroke volume, systemic vascular resistance, and cardiac output, using a Nexfin system and Ivy Biomedical Vital-Guard monitor.
- After a 30 minute baseline monitoring period (time -30 min to 0 min), 4 ½ teaspoons of blood will be collected for osmolality measurement and assays of hormones that regulate blood pressure.
- The subject will then be given 30 mg of pseudoephedrine PO (time 0 min). Monitoring will be continued for 45 minutes.
- At 45 minutes, the participant will be asked to drink 50 ml (Arm 1) or 480 ml (Arm 2) of water.
- Additional blood samples (4 ½ teaspoons) for osmolality and BP-regulating hormones will be collected 30 and 60 minutes after water (+75 and +105 minutes of study).
- Monitoring will be continued until + 135 min.
- At 135 minutes, the study will end for the day. The timing of pseudoephedrine administration relative to water ingestion and the duration of the monitoring period are based on previous results3 and pharmacokinetic data7 reporting a Tmax for pseudoephedrine between 1 and 2 hours. Testing on study day 2 will be identical with the participant consuming the alternate water volume.
Study Testing days 3 and 4 are optional Arm 3: Placebo PO + 50 ml water Arm 4: Placebo PO + 480 ml water Testing will be performed according to the same schedule as for Arms 1 and 2. Instrumentation will be limited to the Dinamap electrocardiographic and blood pressure (brachial cuff) recorder set up for measurements every 5 minutes throughout the study for Arms 3 and 4.
- Conditions
- Shy-Drager Syndrome, Multiple System Atrophy
- Being tested
- Pseudoephedrine + 480 ml water, Pseudoephedrine + 50 ml water, Placebo + 480 ml water (optional), Placebo + 50 ml water (optional)
- Keywords
- Pure Autonomic Failure, Multiple System Atrophy, Pseudoephedrine, Water, Osmopressor
- Medical subject headings
- Shy-Drager Syndrome, Multiple System Atrophy, Pure Autonomic Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoephedrine + 480 ml waterDrug
Also called Sudafed, drinking water
30 mg pseudoephedrine to be given with a pressor dose (480 ml) of drinking water
Pseudoephedrine + 50 ml waterDrug
Also called Sudafed, drinking water
Pseudoephedrine given with a non-pressor (50 ml) dose of drinking water
Placebo + 480 ml water (optional)Other
Also called drinking water
placebo PO with a pressor (480 ml) dose of drinking water
Placebo + 50 ml water (optional)Other
Also called drinking water
placebo PO with a non-pressor (50 ml) dose of drinking water
| Study group | Role | What they receive |
|---|---|---|
| Pseudoephedrine + 480 ml water | Experimental | Pseudoephedrine 30 mg PO 45 minutes before water 480 ml Receives: Drug: Pseudoephedrine + 480 ml water |
| Pseudoephedrine + 50 ml water | Placebo comparator | Pseudoephedrine 30 mg PO 45 minutes before water 50 ml Receives: Drug: Pseudoephedrine + 50 ml water |
| Placebo + 480 ml water (optional) | Experimental | Placebo PO 45 minutes before water 480 ml Receives: Other: Placebo + 480 ml water (optional) |
| Placebo + 50 ml water (optional) | Placebo comparator | Placebo PO 45 minutes before water 50 ml Receives: Other: Placebo + 50 ml water (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure in each Aim will be the peak increase in systolic blood pressure after pseudoephedrine or placebo relative to baseline (delta SBP).
Measured: between 60 and 120 minutes after pseudoephedrine or placebo
Secondary outcomes (6)
Change in diastolic blood pressure relative to baseline
Measured: between 60 and 120 minutes after pseudoephedrine or placebo
Change in heart rate relative to baseline
Measured: between 60 and 120 minutes after pseudoephedrine or placebo
Absolute systolic blood pressure after treatment
Measured: between 60 and 120 minutes after pseudoephedrine and placebo
Absolute diastolic blood pressure after treatment
Measured: between 60 and 120 minutes after pseudoephedrine or placebo
area under the curve for systolic blood pressure from baseline to 135 minutes post-treatment
Area under the curve can better measure an extension of the duration of response.
Measured: from baseline to 135 minutes after pseudoephedrine or placebo
Peak plasma norepinephrine concentration after treatment
Measured: between baseline and 135 minutes after pseudoephedrine or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shy-Drager SyndromeStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Emily M. Garland, Vanderbilt University
- Investigators
- Emily M Garland, PhD, MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149901
- Sponsor's protocol ID
- 140547
- Other IDs
- P01HL056693, UL1TR000445
- Status last verified
- Apr 2021
- First submitted
- 26 May 2014
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Jordan J, Shannon JR, Grogan E, Biaggioni I, Robertson D; New Collective Author. A potent pressor response elicited by drinking water. Lancet. 1999 Feb 27;353(9154):723. doi: 10.1016/S0140-6736(99)99015-3. No abstract available.
PubMed 10073520Jordan J, Shannon JR, Black BK, Ali Y, Farley M, Costa F, Diedrich A, Robertson RM, Biaggioni I, Robertson D; New Collective Author. The pressor response to water drinking in humans : a sympathetic reflex? Circulation. 2000 Feb 8;101(5):504-9. doi: 10.1161/01.cir.101.5.504.
PubMed 10662747Jordan J, Shannon JR, Diedrich A, Black B, Robertson D, Biaggioni I. Water potentiates the pressor effect of ephedra alkaloids. Circulation. 2004 Apr 20;109(15):1823-5. doi: 10.1161/01.CIR.0000126283.99195.37. Epub 2004 Apr 5.
PubMed 15066944Kobayashi S, Endou M, Sakuraya F, Matsuda N, Zhang XH, Azuma M, Echigo N, Kemmotsu O, Hattori Y, Gando S. The sympathomimetic actions of l-ephedrine and d-pseudoephedrine: direct receptor activation or norepinephrine release? Anesth Analg. 2003 Nov;97(5):1239-1245. doi: 10.1213/01.ANE.0000092917.96558.3C.
PubMed 14570629Rothman RB, Vu N, Partilla JS, Roth BL, Hufeisen SJ, Compton-Toth BA, Birkes J, Young R, Glennon RA. In vitro characterization of ephedrine-related stereoisomers at biogenic amine transporters and the receptorome reveals selective actions as norepinephrine transporter substrates. J Pharmacol Exp Ther. 2003 Oct;307(1):138-45. doi: 10.1124/jpet.103.053975. Epub 2003 Sep 3.
PubMed 12954796Lu CC, Diedrich A, Tung CS, Paranjape SY, Harris PA, Byrne DW, Jordan J, Robertson D. Water ingestion as prophylaxis against syncope. Circulation. 2003 Nov 25;108(21):2660-5. doi: 10.1161/01.CIR.0000101966.24899.CB. Epub 2003 Nov 17.
PubMed 14623807Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993 Nov-Dec;13(6 Pt 2):116S-128S; discussion 143S-146S.
PubMed 7507589Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
PubMed 2161310
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure
- ClinicalTrials.gov ID
- NCT02149901
- Acronym / sponsor ID
- 140547
- Conditions
- Shy-Drager Syndrome, Multiple System Atrophy
- Keywords
- Pure Autonomic Failure, Multiple System Atrophy, Pseudoephedrine, Water, Osmopressor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding terminated
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS)
- Study start
- Oct 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 29 May 2014 (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.
The specific aim of this study is to determine whether water ingestion potentiates the pressor response to pseudoephedrine in patients with primary disorders of autonomic failure. The study design will enable us to also evaluate the pressor response to water alone and to pseudoephedrine alone. In a secondary analysis, we will compare the results in patients with two autonomic disorders, pure autonomic failure (PAF) and multiple system atrophy (MSA). We hypothesize that drinking water following a dose of pseudoephedrine will lead to a greater increase in blood pressure than pseudoephedrine alone.
Detailed description
The maximal pressor response to water is reached when other pressor agents are only beginning to act. In addition to the therapeutic value of water ingestion alone, the blood pressure-raising effects of agents that increase sympathetic nervous system tone, such as phenylpropanolamine, are potentiated by water drinking. These drug interaction effects can be exploited in the treatment of orthostatic hypotension with the combination of water and a sympathomimetic potentially able to increase blood pressure to a greater extent and for a longer period of time than either water or the medication alone. However, the interaction can also lead to potentially dangerous blood pressure surges.
This protocol requires an initial screening history and physical of study participants, including safety labs and EKGs, and evaluation of their autonomic nervous system status following the consent process. If the patient meets study criteria and is willing to undergo study testing, the 4-way crossover protocol will follow.
Study Testing days 1 and 2 Arm 1: Pseudoephedrine 30 mg PO + 50 ml water Arm 2: Pseudoephedrine 30 mg PO + 480 ml water
- Testing will be performed at the same time of day for all studies, at least 2 hours after a meal to avoid any confounding effects from postprandial hypotension.
- A saline lock will be inserted for blood sampling at least 30 minutes before baseline data collection.
- Participants will be asked to empty their bladders before beginning the test to avoid any effect of a full urinary bladder on peripheral sympathetic activity.
- Participants will be seated comfortably in a chair. They will be asked to remain in the seated position for the duration of the study.
- The Dinamap electrocardiographic and blood pressure (brachial cuff) recorder will be attached to the patient and set up for measurements every 5 minutes throughout the study with digital download into the ADC (Autonomic Dysfunction Center) BP database.
- Participants will also be instrumented with EKG, finger cuff and sensor for continuous monitoring of blood pressure, heart rate, respiration, SpO2, stroke volume, systemic vascular resistance, and cardiac output, using a Nexfin system and Ivy Biomedical Vital-Guard monitor.
- After a 30 minute baseline monitoring period (time -30 min to 0 min), 4 ½ teaspoons of blood will be collected for osmolality measurement and assays of hormones that regulate blood pressure.
- The subject will then be given 30 mg of pseudoephedrine PO (time 0 min). Monitoring will be continued for 45 minutes.
- At 45 minutes, the participant will be asked to drink 50 ml (Arm 1) or 480 ml (Arm 2) of water.
- Additional blood samples (4 ½ teaspoons) for osmolality and BP-regulating hormones will be collected 30 and 60 minutes after water (+75 and +105 minutes of study).
- Monitoring will be continued until + 135 min.
- At 135 minutes, the study will end for the day. The timing of pseudoephedrine administration relative to water ingestion and the duration of the monitoring period are based on previous results3 and pharmacokinetic data7 reporting a Tmax for pseudoephedrine between 1 and 2 hours. Testing on study day 2 will be identical with the participant consuming the alternate water volume.
Study Testing days 3 and 4 are optional Arm 3: Placebo PO + 50 ml water Arm 4: Placebo PO + 480 ml water Testing will be performed according to the same schedule as for Arms 1 and 2. Instrumentation will be limited to the Dinamap electrocardiographic and blood pressure (brachial cuff) recorder set up for measurements every 5 minutes throughout the study for Arms 3 and 4.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pseudoephedrine + 480 ml water | Experimental | Drug: Pseudoephedrine + 480 ml waterPseudoephedrine 30 mg PO 45 minutes before water 480 ml |
| Pseudoephedrine + 50 ml water | Placebo comparator | Drug: Pseudoephedrine + 50 ml waterPseudoephedrine 30 mg PO 45 minutes before water 50 ml |
| Placebo + 480 ml water (optional) | Experimental | Other: Placebo + 480 ml water (optional)Placebo PO 45 minutes before water 480 ml |
| Placebo + 50 ml water (optional) | Placebo comparator | Other: Placebo + 50 ml water (optional)Placebo PO 45 minutes before water 50 ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years, with
- Neurogenic orthostatic hypotension, ≥30 mmHg drop in SBP within 5 minutes of standing,
- Associated with impaired autonomic reflexes, as determined by absence of blood pressure overshoot during phase IV of the valsalva maneuver,
- Absence of other identifiable causes of autonomic neuropathy, and
- Able and willing to provide informed consent
Key exclusion criteria (11 listed)
- Pregnancy
- Current smoking habit
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathy of unknown significance, and autoimmune neuropathies.
- Known intolerance to pseudoephedrine
- Pre-existing sustained severe hypertension (BP > 180/110 mmHg in the sitting position)
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 |
|---|---|---|
| Pseudoephedrine + 480 ml waterAlso: Sudafed, drinking water30 mg pseudoephedrine to be given with a pressor dose (480 ml) of drinking water | Drug | Pseudoephedrine + 480 ml water |
| Pseudoephedrine + 50 ml waterAlso: Sudafed, drinking waterPseudoephedrine given with a non-pressor (50 ml) dose of drinking water | Drug | Pseudoephedrine + 50 ml water |
| Placebo + 480 ml water (optional)Also: drinking waterplacebo PO with a pressor (480 ml) dose of drinking water | Other | Placebo + 480 ml water (optional) |
| Placebo + 50 ml water (optional)Also: drinking waterplacebo PO with a non-pressor (50 ml) dose of drinking water | Other | Placebo + 50 ml water (optional) |
Primary outcome
The primary outcome measure in each Aim will be the peak increase in systolic blood pressure after pseudoephedrine or placebo relative to baseline (delta SBP).
Time frame: between 60 and 120 minutes after pseudoephedrine or placebo
6 secondary outcomes
Change in diastolic blood pressure relative to baseline
Time frame: between 60 and 120 minutes after pseudoephedrine or placebo
Change in heart rate relative to baseline
Time frame: between 60 and 120 minutes after pseudoephedrine or placebo
Absolute systolic blood pressure after treatment
Time frame: between 60 and 120 minutes after pseudoephedrine and placebo
Absolute diastolic blood pressure after treatment
Time frame: between 60 and 120 minutes after pseudoephedrine or placebo
area under the curve for systolic blood pressure from baseline to 135 minutes post-treatment
Time frame: from baseline to 135 minutes after pseudoephedrine or placebo
Peak plasma norepinephrine concentration after treatment
Time frame: between baseline and 135 minutes after pseudoephedrine or placebo
Results and safety
The study was stopped early (reason given: funding terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Background: PubMed 10073520Jordan J, Shannon JR, Grogan E, Biaggioni I, Robertson D; New Collective Author. A potent pressor response elicited by drinking water. Lancet. 1999 Feb 27;353(9154):723. doi: 10.1016/S0140-6736(99)99015-3. No abstract available.
- Background: PubMed 10662747Jordan J, Shannon JR, Black BK, Ali Y, Farley M, Costa F, Diedrich A, Robertson RM, Biaggioni I, Robertson D; New Collective Author. The pressor response to water drinking in humans : a sympathetic reflex? Circulation. 2000 Feb 8;101(5):504-9. doi: 10.1161/01.cir.101.5.504.
- Background: PubMed 15066944Jordan J, Shannon JR, Diedrich A, Black B, Robertson D, Biaggioni I. Water potentiates the pressor effect of ephedra alkaloids. Circulation. 2004 Apr 20;109(15):1823-5. doi: 10.1161/01.CIR.0000126283.99195.37. Epub 2004 Apr 5.
- Background: PubMed 14570629Kobayashi S, Endou M, Sakuraya F, Matsuda N, Zhang XH, Azuma M, Echigo N, Kemmotsu O, Hattori Y, Gando S. The sympathomimetic actions of l-ephedrine and d-pseudoephedrine: direct receptor activation or norepinephrine release? Anesth Analg. 2003 Nov;97(5):1239-1245. doi: 10.1213/01.ANE.0000092917.96558.3C.
- Background: PubMed 12954796Rothman RB, Vu N, Partilla JS, Roth BL, Hufeisen SJ, Compton-Toth BA, Birkes J, Young R, Glennon RA. In vitro characterization of ephedrine-related stereoisomers at biogenic amine transporters and the receptorome reveals selective actions as norepinephrine transporter substrates. J Pharmacol Exp Ther. 2003 Oct;307(1):138-45. doi: 10.1124/jpet.103.053975. Epub 2003 Sep 3.
- Background: PubMed 14623807Lu CC, Diedrich A, Tung CS, Paranjape SY, Harris PA, Byrne DW, Jordan J, Robertson D. Water ingestion as prophylaxis against syncope. Circulation. 2003 Nov 25;108(21):2660-5. doi: 10.1161/01.CIR.0000101966.24899.CB. Epub 2003 Nov 17.
- Background: PubMed 7507589Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993 Nov-Dec;13(6 Pt 2):116S-128S; discussion 143S-146S.
- Background: PubMed 2161310Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
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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.
Emily M Garland, PhD, MSCI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pseudoephedrine + 480 ml water and Pseudoephedrine + 50 ml water in people with Shy-Drager Syndrome and Multiple System Atrophy, run by Vanderbilt University 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 May 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: funding terminated). Results are not available in the source record.
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?
The primary outcome measure in each Aim will be the peak increase in systolic blood pressure after pseudoephedrine or placebo relative to baseline (delta SBP). (time frame: between 60 and 120 minutes after pseudoephedrine or placebo). 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 NCT02149901, which also lists 8 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 5 May 2021.