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Cholinesterase Inhibitor

Rivastigmine for Anticholinergic Toxicity (RIVA-AM Trial)

Phase 2

Waitlist Available

Led By Kevin Baumgartner, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

10 years of age or older

Reasonably likely to benefit from antidotal therapy for antimuscarinic delirium, as demonstrated by clinically significant agitation and delirium: Richmond Agitation-Sedation Scale (RASS) of +1 or higher at the time of enrollment, Positive for delirium as defined by the Confusion Assessment Method for the ICU (CAM-ICU)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up typically 8-36 hours after randomization

Awards & highlights

RIVA-AM Trial Summary

"This trial aims to study a potential new treatment, rivastigmine, for a toxic condition called antimuscarinic delirium. The current standard treatment, physostigmine, is not

Who is the study for?

This trial is for individuals experiencing antimuscarinic delirium, a type of confusion and agitation due to certain medication or chemical poisoning. Details on who can join are not provided, but typically participants must meet specific health criteria.Check my eligibility

What is being tested?

The study tests if rivastigmine helps treat antimuscarinic delirium faster than a placebo. Participants will be randomly assigned to receive either rivastigmine or an inactive substance (placebo) in this controlled trial.See study design

What are the potential side effects?

While the side effects of rivastigmine aren't listed here, common ones may include nausea, vomiting, diarrhea, dizziness, and headache. The severity can vary from person to person.

RIVA-AM Trial Eligibility Criteria

Inclusion Criteria

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

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I am at least 10 years old.

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I am experiencing significant agitation and confusion that could improve with specific treatment.

RIVA-AM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ typically 8-36 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~typically 8-36 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and typically 8-36 hours after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to control of agitation and delirium

Secondary outcome measures

Bradycardia

Disposition

Duration of agitation and delirium

+8 more

Side effects data

From 2014 Phase 1 & 2 trial • 42 Patients • NCT01084135

42%

Stomach ache

25%

Diarrhea

25%

Cold

25%

Vomiting

25%

Nausea

17%

Menstural cramps

17%

Stomach flu

17%

Sleepy

Weakness

Itchy

Eye twitch

Headache

Worsening acne

Indigestion

Fatigue

Foot twitching

Leg cramps

Assertive, stubborn, more emotional

Fainted

Rash

Nasal congestion

Lumps in neck

Restless legs

Pale coloring

Dizziness

Trouble sleeping

Decreased appetite

Boil

Cut

Constipation

Incontinence

100%

80%

60%

40%

20%

Study treatment Arm

20 Week: Rivastigmine- Liquid Form

20 Week: Liquid Placebo

12 Week: Liquid Placebo

12 Week: Rivastigmine- Liquid Form

RIVA-AM Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RivastigmineExperimental Treatment1 Intervention

Patients in the rivastigmine arm will receive rivastigmine 3mg by mouth once, followed by rivastigmine 1.5mg by mouth every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for up to three doses.

Group II: PlaceboPlacebo Group1 Intervention

Patients in the placebo arm will receive oral placebo by mouth once, followed by oral placebo every 1 hour as needed for ongoing delirium or agitation (at the discretion of the treating physician), for up to three doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rivastigmine

2018

Completed Phase 4

~1260

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,940 Previous Clinical Trials

2,303,353 Total Patients Enrolled

American Academy of Clinical ToxicologyUNKNOWN

1 Previous Clinical Trials

19 Total Patients Enrolled

Kevin Baumgartner, MDPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with Rivastigmine use in individuals?

"The safety assessment for Rivastigmine has been rated a 2 by our team at Power on a scale of 1 to 3. This rating is due to the ongoing Phase 2 trial, which currently lacks efficacy data but shows promise in terms of safety based on available information."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rivastigmine for Antimuscarinic Delirium

Kevin Baumgartner 2024. "Rivastigmine for Antimuscarinic Delirium". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06382649.

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