Remimazolam for Brain Activity

(REMAZ Trial)

Overseen By Keith M Vogt, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Keith M Vogt

Must not be taking: Antiepileptics, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Chronic pain, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial examines how remimazolam, a sedative medication, affects brain activity and memory. Participants will receive the drug and undergo MRI scans to observe brain reactions during rest, pain, or memory tasks. The trial seeks adults without chronic pain, memory issues, or certain health conditions like anxiety or high blood pressure. Participants should not use drugs, smoke daily, or have non-removable metal in their bodies for the MRI. Generally healthy individuals curious about their brain's response to medication may find this trial suitable. As an Early Phase 1 trial, this research focuses on understanding how remimazolam works in people, offering a chance to contribute to groundbreaking medical knowledge.

Is there any evidence suggesting that remimazolam is likely to be safe for humans?

Research has shown that remimazolam is generally well-tolerated by many patients. It has proven safe for adults with serious health issues, indicating its reliability even for those with significant health concerns. Studies comparing remimazolam to propofol, a commonly used sedative, found it safe and effective, particularly during procedures like MRI scans.

Although remimazolam is approved for certain uses, its safety in children remains unconfirmed. In adults, however, small doses have effectively eased anxiety during procedures like brain MRIs while maintaining an open airway. This suggests it can calm patients without causing breathing problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about remimazolam because it offers a unique approach to managing brain activity during painful stimuli. Unlike traditional sedatives or pain management options, remimazolam is a fast-acting sedative with a short duration, which means it can provide quick sedation and recovery. This rapid action is particularly useful in settings where precise control over sedation levels is needed, minimizing prolonged effects and potential side effects. Additionally, remimazolam's mechanism of action targets specific receptors in the brain, offering a potentially safer alternative with fewer complications compared to longer-acting sedatives.

What evidence suggests that remimazolam might be an effective treatment for brain activity?

Research has shown that remimazolam might aid memory and learning. In studies with rats, remimazolam improved memory and learning after surgery. Other research indicates that remimazolam causes less short-term memory loss compared to midazolam, a similar drug. Researchers have found it safe and effective when used with other sedation drugs during procedures. This trial will investigate remimazolam's effects on brain activity, as all participants will receive remimazolam along with painful electric nerve stimulation while undergoing MRI imaging. This suggests remimazolam could positively affect brain activity and thinking skills. ^{1 2 6 7 8}

Who Is on the Research Team?

Keith M Vogt, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic persistent surgical pain. Participants should be suitable candidates for an MRI and peripheral nerve stimulation, with no exclusions specified in the provided information.

Inclusion Criteria

Have none of the specific exclusion criteria

I have a working email and phone number.

I am between 18 and 59 years old.

Exclusion Criteria

Pregnant or attempting to conceive

Body mass index (BMI) > 35

Significant memory impairment or hearing loss

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive remimazolam and undergo MRI scans during noxious stimulation and memory encoding tasks

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 days

What Are the Treatments Tested in This Trial?

Interventions

• Remimazolam

Trial Overview

The study investigates how remimazolam affects cognition, brain activity, and connectivity. It involves resting state assessments, responses to painful stimuli, and memory tasks during functional MRI scans.

How Is the Trial Designed?

Group I: Remimazolam+Pain Experimental Treatment 2 Interventions

Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.

Who Is Running the Clinical Trial?

Keith M Vogt

Lead Sponsor

Trials

4

Recruited

210+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07290205

Study Details | NCT07290205 | Remimazolam NeuroImaging

Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam. Day/Visit 1: during no-drug condition MRI ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12543097/

Comparative Evaluation of Remimazolam Besylate versus ...

This study aims to evaluate whether remimazolam besylate is superior to propofol in terms of safety and effectiveness for sedation in pediatric ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006899324002294

Remimazolam inhibits postoperative cognitive impairment ...

The results showed that remimazolam improved the memory and learning abilities in CPB rats. CPB rats and LPS-treated microglia showed increased ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11922631/

Clinical Experience With Remimazolam in ... - PubMed Central

The authors concluded that remimazolam, when supplemented with propofol or ketamine, was a safe and effective agent for procedural sedation. Villalobos et al [ ...

5.

link.springer.com

link.springer.com/article/10.1186/s40001-024-02142-6

Effect of remimazolam toluene sulfonate on the cognitive ...

Furthermore, our data demonstrated that the short-term memory damage caused by remimazolam is lighter than midazolam. Concurrently, the extent ...

6.

byfavo.com

byfavo.com/safety

Safety in high-risk ASA-PS III-IV patients

Established safety in a diverse range of adult patients, including high-risk ASA-PS III-IV patients. Safety in high-risk ASA-PS III-IV patients.

7.

apsf.org

apsf.org/article/remimazolam-patient-safety-considerations-of-a-novel-practice-changing-drug-in-perioperative-medicine/

Remimazolam: Patient Safety Considerations of a Novel ...

Small doses can provide enough patient anxiolysis while maintaining a patent airway to complete a brain MRI. At the time this article was written, we do not ...

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/212295s000lbl.pdf

BYFAVO (remimazolam) - accessdata.fda.gov

Safety and effectiveness in pediatric patients have not been established. No studies are available in any pediatric population and extrapolation of adult ...