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Antipsychotic

INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD (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

Summary

This trial tests a new nasal spray treatment for calming agitation in young people with autism. The spray delivers a drug called olanzapine quickly through the nose. Olanzapine has been studied for its effectiveness in treating behavioral problems in children and adolescents, including those with autism. The study aims to see if this method is safe and effective for those who don't respond well to other treatments.

Eligible Conditions
  • Agitation in Autism Spectrum Disorder

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
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

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

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
Stephen Shrewsbury, MDStudy ChairImpel Pharmaceuticals
Craig Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
155 Total Patients Enrolled
Matthew Siegel, MDPrincipal InvestigatorMaine Behavioral Healthcare
~2 spots leftby Dec 2025
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