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Psychostimulant

Modafinil for Postural Orthostatic Tachycardia Syndrome (POTS)

Phase < 1
Waitlist Available
Led By Italo Biaggioni, M.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 hours post study medication
Awards & highlights

Study Summary

This trial will test if the drug modafinil can help improve cognitive function in patients with POTS.

Who is the study for?
This trial is for people aged 18-60 diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center. Participants must be able to consent and not have allergies to study meds, be pregnant or breastfeeding, dehydrated, bedridden, taking certain antidepressants (SNRIs/NET inhibitors), or have asthma due to propranolol's risks.Check my eligibility
What is being tested?
The study aims to see if modafinil can improve 'brain fog' in POTS patients. It involves comparing the effects of modafinil and a placebo on cognitive function when seated. Propranolol is also being tested as part of the treatment strategy.See study design
What are the potential side effects?
Modafinil may cause headaches, nausea, nervousness, dizziness, difficulty sleeping. Propranolol might lead to lower heart rate, fatigue, dizziness and could worsen asthma symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 hours post study medication
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 hours post study medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Attention Performance Speed
Secondary outcome measures
Blood Pressure
Executive Function
Heart Rate
Other outcome measures
Processing speed
Visual learning and memory
Working memory

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PropranololExperimental Treatment2 Interventions
Patients will receive single doses of propranolol (20 mg, oral) and placebo on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Group II: Modafinil plus PropranololExperimental Treatment2 Interventions
Patients will receive single doses of modafinil (200 mg, oral) and propranolol (20 mg, oral) on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Group III: ModafinilExperimental Treatment2 Interventions
Patients will receive single doses of modafinil (200 mg, oral) and placebo on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Group IV: PlaceboPlacebo Group1 Intervention
Patients will receive two inactive placebo pills filled with microcrystalline cellulose on a randomized study day. Medications will be dummy blinded to the patient and investigators.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modafinil
2002
Completed Phase 4
~1700
Placebo
1995
Completed Phase 3
~2670
Propranolol
2010
Completed Phase 4
~1290

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
320 Previous Clinical Trials
401,710 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
55 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,172 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
889 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Italo Biaggioni, M.D.Principal InvestigatorVanderbilt University Medical Center
6 Previous Clinical Trials
191 Total Patients Enrolled

Media Library

Modafinil (Psychostimulant) Clinical Trial Eligibility Overview. Trial Name: NCT01988883 — Phase < 1
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Modafinil plus Propranolol, Propranolol, Placebo, Modafinil
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Modafinil Highlights & Side Effects. Trial Name: NCT01988883 — Phase < 1
Modafinil (Psychostimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01988883 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Modafinil and Cognitive Function in POTS
Italo Biaggioni 2014. "Modafinil and Cognitive Function in POTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01988883.
~1 spots leftby Dec 2024
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