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Norepinephrine Transport Inhibitor

Atomoxetine for Fainting (Vasovagal Syncope) (POST7 Trial)

Phase 3

Recruiting

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 2 vasovagal syncope spells in the preceding 12 months

At least 18 years old with informed consent

Must not have

Pheochromocytoma

Other cause of syncope

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months of the study up to 12 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether atomoxetine, a drug used to treat attention deficit disorder, can prevent fainting in people with recurrent vasovagal syncope.

Who is the study for?

This trial is for adults who've fainted at least twice in the past year due to vasovagal syncope, as defined by American College of Cardiology Guidelines. Participants must be over 18 and score at least -2 on a specific Syncope Symptom Score. Those with uncontrolled blood pressure or thyroid issues, pacemakers, certain eye conditions, or taking conflicting medications cannot join.

What is being tested?

The study tests if Atomoxetine Hydrochloride (40 mg twice daily) can prevent fainting in people with recurrent vasovagal syncope compared to a placebo. It's a double-blind crossover trial where patients switch between the drug and placebo after six months with a one-week break in between.

What are the potential side effects?

While not specified here, common side effects of Atomoxetine may include dry mouth, nausea, decreased appetite, dizziness, trouble sleeping and mood swings. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have fainted at least twice in the last year.

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I am over 18 and understand the details of the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with pheochromocytoma.

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I have experienced fainting due to reasons other than my heart.

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I have a significant heart condition.

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My thyroid is overactive and not controlled by medication.

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I have been diagnosed with Orthostatic Hypotension or POTS after a stand test.

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I have taken a monoamine oxidase inhibitor recently.

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I have used atomoxetine for fainting spells before.

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My high blood pressure is not under control.

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I have glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months of the study up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months of the study up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months of the study up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The measure will be the proportion of patients having at least one syncope recurrence.

Secondary study objectives

EQ-5D-3L

Generalized Anxiety Disorder score

Hospital Anxiety and Depression Scale (HADS)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AtomoxetineActive Control1 Intervention

Atomoxetine 40 mg PO BID (morning and late afternoon) Dosing will start at 40 mg daily for 3 days1 week, followed by a forced titration to 40 mg BID, as per the FDA label for atomoxetine.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo will be identical in appearance to the active treatment pill. BID (morning and late afternoon)

0 / 11Eligibility criteria met