Guanfacine + Cromolyn Sodium for POTS
(DBPOTS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether guanfacine or cromolyn sodium can improve symptoms and physical functioning in adults with Postural Orthostatic Tachycardia Syndrome (POTS). Both medications are FDA-approved for other conditions but are investigational for the treatment of POTS.
The main questions this study aims to answer are:
Does treatment with guanfacine or cromolyn sodium improve physical functioning in adults with POTS compared with placebo? Does treatment with guanfacine or cromolyn sodium improve fatigue, cognitive function ("brain fog"), gastrointestinal symptoms, and overall symptom burden in adults with POTS?
Researchers will compare guanfacine, cromolyn sodium, and placebo to determine whether either active treatment provides greater improvement in symptoms and physical functioning than placebo.
Participants will:
Be randomly assigned to receive guanfacine, cromolyn sodium, and placebo during separate 4-week treatment periods in a randomized, double-blind crossover study.
Continue standard non-drug POTS management, including recommendations for fluid and salt intake, exercise, compression garments, and other lifestyle measures.
Complete questionnaires that measure physical function, fatigue, cognitive symptoms, gastrointestinal symptoms, and overall health throughout the study.
Attend scheduled study visits for safety monitoring and assessment of study outcomes.
Provide blood, urine, and sputum samples so researchers can evaluate biomarkers related to POTS and better understand how these treatments may work.
Who Is on the Research Team?
Malcolm Brock, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with POTS who developed symptoms within 3 months of a known trigger (like infection or surgery), have ongoing dizziness or rapid heartbeat when standing, and meet specific heart rate criteria. People can't join if they are pregnant, breastfeeding, have certain medical conditions like active infections or thyroid problems, or take medications that can't be stopped.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive guanfacine, cromolyn sodium, and placebo during separate 4-week treatment periods in a randomized, double-blind crossover study
Washout
2-week washout interval between each 4-week treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cromolyn Sodium
- Guanfacine
Trial Overview
The study tests whether guanfacine or cromolyn sodium can improve physical function and reduce symptoms in adults with POTS compared to placebo. Participants receive each treatment and placebo during separate 4-week periods in random order while continuing standard non-drug care.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants receive oral guanfacine during one 4-week treatment period, with dose escalation permitted according to protocol if clinically indicated.
Participants receive oral cromolyn sodium during one 4-week treatment period, with protocol-defined dose escalation if needed.
Participants receive matched placebo during one 4-week treatment period to maintain blinding.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Dysautonomia International
Collaborator
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