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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

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

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

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

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
Craig Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
155 Total Patients Enrolled
~3 spots leftby Jul 2025
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