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.
a heart rate increase of ≥30 bpm within the first 10 minutes of standing or tilt-table testing, without orthostatic hypotension (systolic BP drop ≥20 mmHg)
Frequent symptoms of orthostatic intolerance (e.g., dizziness, palpitations, GI complaints) persisting ≥3 months
Symptom onset within 3 months of a recognized POTS trigger (e.g., infection, vaccination, injury, surgery, pregnancy, or puberty)
Symptomatic response to mediator-targeting medications (e.g., antihistamines, mast cell stabilizers) - also eligible
Anemia,
Active infection,
Dehydration,
Hyperthyroidism,
Crossover
Guanfacine (GFC)
DrugParticipants receive oral guanfacine for 4 weeks while continuing standardized non-pharmacologic management of POTS. Guanfacine is initiated at 1 mg once daily and may be increased to 2 mg once daily at Week 3 if adequate clinical improvement has not been achieved and the medication is well tolerated. Participants complete symptom assessments and safety evaluations throughout the treatment period.
Cromolyn Sodium
DrugParticipants receive oral cromolyn sodium for 4 weeks while continuing standardized non-pharmacologic management of POTS. Treatment begins at 200 mg twice daily (400 mg/day) and may be increased to 400 mg twice daily (800 mg/day). For participants who tolerate treatment but have an inadequate response, the dose may be further increased to 1,600 mg/day according to the protocol. Symptom assessments and safety evaluations are performed throughout the treatment period.
Placebo
DrugParticipants receive matched placebo for 4 weeks while continuing standardized non-pharmacologic management of POTS. Placebo products are matched to the active study medications, including identical dose-escalation procedures, to maintain blinding. Participants complete the same symptom assessments and safety evaluations as during the active treatment periods.
Change in Physical Function as Measured by the PROMIS® Physical Function Scale
Scores are reported as T-scores based on a U.S. population average of 50, with a standard deviation of 10. Higher scores indicate better physical function.
Patient-Reported Outcomes Measurement Information System (PROMIS®) Fatigue
T-score (mean = 50, SD = 10). Higher T-scores indicate greater fatigue (worse outcome).
Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function
T-score (mean = 50, SD = 10). Higher T-scores indicate better cognitive function (better outcome).
Clinical Global Impressions (CGI)
Score ranges from 1 to 7. Higher scores indicate greater illness severity or worsening (worse outcome).
Malmö Postural Orthostatic Tachycardia Syndrome Symptom Score
Total score ranges from 0 to 120. Higher scores indicate greater POTS symptom burden (worse outcome).
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Johns Hopkins University
Lead sponsor
Dysautonomia International
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
