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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
Displays episodes of moderate to severe agitation
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You show signs of being very upset or restless.

CALM 201 Trial 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

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

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

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
Cincinnati Children's Hospital Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Feb 2025