INP105 for Akathisia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Akathisia+5 More
INP105 - CombinationProduct
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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
  • Akathisia
  • Agitation in Adolescents and Young Adults With ASD
  • Agitation in Adolescents With Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Akathisia

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: From dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable

Dosing until 120 minutes post-dose
Frequency of administering pharmaceutical rescue intervention within 120 after dosing
Frequency of administering pharmaceutical rescue intervention within 120 minutes after dosing
Time to reach an ACES score of 4 (normal) post-dosing
Hour 48
Incidence of adverse events and serious adverse events in the INP105 and placebo groups up to 48 hours post-dose
Day 7
Overall incidence of adverse events and serious adverse events in the INP105 and placebo groups
Pre-dose and at 60 minutes post-dose
Change in modified Aberrant Behavior Checklist - Irritability Subscale (ABC-I) score at 60 minutes post-dose
Pre-dose to 30 minutes post-dose
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
Change in Positive and Negative Syndrome Scale - Excited Component (PEC) score at 30 minutes post-dose
Change in irritability behavior frequency counts at 30 minutes post-dose
Clinical Global Impressions - Efficacy (CGI-E) score at 30 minutes post-dose
Clinical Global Impressions - Improvement (CGI-I) score at 30 minutes post-dose

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Akathisia

Trial Design

2 Treatment Groups

INP105
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

32 Total Participants · 2 Treatment Groups

Primary Treatment: INP105 · Has Placebo Group · Phase 2

INP105
CombinationProduct
Experimental Group · 1 Intervention: INP105 · Intervention Types: CombinationProduct
Placebo
CombinationProduct
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: CombinationProduct
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INP105
2018
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable

Who is running the clinical trial?

Impel PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
466 Total Patients Enrolled
Impel NeuroPharma Inc.Lead 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
Stephen Shrewsbury, MDStudy ChairImpel Pharmaceuticals
Matthew Siegel, MDPrincipal InvestigatorMaine Behavioral Healthcare

Eligibility Criteria

Age < 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been diagnosed with autism spectrum disorder.
You are admitted as an inpatient to a behavioral unit prior to informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.