Rivastigmine for Delirium
(RIVA-AM Trial)

Recruiting in 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

Diagnosis of antimuscarinic delirium by history and physical examination, in the opinion of the treating attending toxicologist

I am at least 10 years old.

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

Exclusion Criteria

I am under 10 years old.

Patient is pregnant or a ward of the state

Inability to safely tolerate oral medication, in the judgement of the treating attending physician

+2 more

Participant Groups

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: