Rivastigmine for Delirium (RIVA-AM Trial)

Palo Alto (17 mi)

Overseen byKevin Baumgartner, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production. Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo.

Eligibility Criteria

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.

Inclusion Criteria

I am at least 10 years old.

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

Exclusion Criteria

Evidence of significant risk for serious cardiac or neurologic sequelae of antimuscarinic poisoning: Any known or suspected seizure activity prior to enrollment, QRS duration >100 milliseconds on EKG at enrollment, Any ventricular dysrhythmia prior to enrollment, Respiratory failure of any etiology requiring endotracheal intubation, Any hypotension at enrollment, Any administration of sodium bicarbonate, hypertonic saline, vasopressors, inotropes, antiarrhythmic agents, or intravenous lipid emulsion prior to enrollment, Unacceptable risk of serious medical sequelae of antimuscarinic poisoning in the judgment of the treating attending toxicologist, Evidence of significant risk of adverse effect of AChE-I: Bradycardia or risk of AChE-I induced bradycardia at enrollment, Known or suspected seizure disorder, History of asthma or COPD or wheezing during index presentation, Known or suspected physical obstruction of intestinal or urogenital tract, Known or suspected peptic ulcer disease, Any known allergy or intolerance to rivastigmine or other AChEI

I am under 10 years old.

Treatment Details

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.

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.

Rivastigmine is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Exelon for: