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Antipsychotic

INP105 for Agitation in Autism Spectrum Disorder (CALM 201 Trial)

Phase 2

Waitlist Available

Led By Craig Erickson, MD

Research Sponsored by Impel NeuroPharma Inc.

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable

Awards & highlights

CALM 201 Trial Summary

This trial is a Phase 2a, proof-of-concept, 2-way, 2-period crossover, double-blind study to evaluate the safety and efficacy of INP105 as an acute treatment versus placebo in adolescents with autism spectrum disorder (ASD) experiencing agitation.

Eligible Conditions

Agitation in Autism Spectrum Disorder

CALM 201 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable

This trial's timeline: 3 weeks for screening, Varies for treatment, and from dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of adverse events and serious adverse events in the INP105 and placebo groups up to 48 hours post-dose

Overall incidence of adverse events and serious adverse events in the INP105 and placebo groups

Secondary outcome measures

Change in Agitation-Calmness Evaluation Scale (ACES) score at 30 minutes post-dose

Change in Behavioral Activity Rating Scale (BARS) score at 30 minutes post-dose

Change in Overt Aggression Scale (OAS) score at 30 minutes post-dose

+7 more

CALM 201 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INP105Experimental Treatment1 Intervention

POD-olanzapine (INP105), 5 mg, single dose, to be delivered to each participant

Group II: PlaceboPlacebo Group1 Intervention

POD-placebo, single dose, to be delivered to each participant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INP105

2018

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Impel NeuroPharma Inc.Lead Sponsor

4 Previous Clinical Trials

466 Total Patients Enrolled

Impel PharmaceuticalsLead Sponsor

4 Previous Clinical Trials

466 Total Patients Enrolled

Craig Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

4 Previous Clinical Trials

145 Total Patients Enrolled

Frequently Asked Questions

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

Does this medical trial accept applicants of advanced age?

"The age limits for participation in this medical trial are between 12 and 21 years old."

Answered by AI

How many participants are enrolled in this research?

"Confirmed. According to clinicaltrials.gov, this trial was initially made public on June 23rd 2022 and has been actively searching for 32 patients across 2 distinct sites since its last edit in October 21st 20202."

Answered by AI

Has the INP105 drug been confirmed to meet all necessary requirements for use by the Food and Drug Administration?

"Our team at Power has judged the safety of INP105 to be 2, as it is currently in Phase 2 clinical trials and only limited evidence for its efficacy exists."

Answered by AI

Is it possible for me to enroll in this medical experiment?

"For this medical trial, 32 participants aged 12-21 with akathisia must fulfill the following requirements: formal diagnosis of autism spectrum disorder, episodes of significant to extreme agitation, and inpatient status previous to giving valid consent."

Answered by AI

What are the main aims of this medical experiment?

"The purpose of this clinical trial, which will evaluate patients from dosing to 48 hours after, is to gauge the general incidence of adverse effects and serious risks associated with INP105 and its placebo counterpart. Secondary objectives consist of assessing changes in Behavioral Activity Rating Scale (BARS), Agitation-Calmness Evaluation Scale (ACES), and Overt Aggression Scale (OAS) scores thirty minutes post-dosage. The BARS ranges from 1 meaning "difficult or unable to rouse" to 4 representing "quiet and awake (normal level of activity)" up until 7 denoting a need for restraint due to violent behavior."

Answered by AI

Are there still openings available for participation in this research project?

"Affirmative. According to clinicialtrials.gov, this medical trial is still open and actively recruiting patients since its initial posting on June 23rd 2022. The most recent update came on October 21st 2022, seeking 32 participants from 2 locations."

Answered by AI