Trial · NCT05163717
INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD
NCT05163717, Phase 2, Terminated, Impel Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD. Trials, record NCT05163717. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05163717
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- INP105 Proof-of-concept Study for the Acute Treatment of Agitation in Adolescents and Young Adults With ASD
- NCT number
- NCT05163717
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Impel Pharmaceuticals
- Conditions
- Agitation in Adolescents and Young Adults With ASD
- Interventions
- INP105, Placebo
- First posted
- 2021-12-20
- Last updated
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events and serious adverse events in the INP105 and placebo groups up to 48 hours post-dose | From dosing to 48 hours post dosing | All adverse events, serious or not, will be recorded from time of dosing with either INP105 or placebo up until 48 hours post-dose, or until the next treatment is given, which ever is sooner. |
| Primary | Overall incidence of adverse events and serious adverse events in the INP105 and placebo groups | From dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable | All adverse events will be recorded as treatment emergent from after dosing until the next treatment, or until last study visit, as applicable. |
| Secondary | Change in Agitation-Calmness Evaluation Scale (ACES) score at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | The ACES is a 9 point scale that measures the degree of agitation versus sedation, ranging from a score of 1 "marked agitation" to 4 "normal" to 9 "unable to be aroused". |
| Secondary | Change in Behavioral Activity Rating Scale (BARS) score at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | The BARS is a 7 point scale measuring the degree of agitated behavior, ranging from 1 "difficult or unable to rouse" to 4 "quiet and awake (normal level of activity)" to 7 "violent, requires restraint. |
| Secondary | Change in Overt Aggression Scale (OAS) score at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | The OAS measures the degree of aggression, using 4 categories of aggression, defined as "verbal aggression", "aggression against objects", "aggression against self", and "aggression against other people". The higher a category is rated, the more severe the degree of aggression. The total score is the sum of the scores from the 4 categories. |
| Secondary | Change in Positive and Negative Syndrome Scale - Excited Component (PEC) score at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | The PEC describes 5 behaviors related to negative aspects of excitability; excitement, tension, hostility, uncooperativeness, poor impulse control. The rater scores each of these aspects from 1 (not present) to 7 (extreme), for a total score that can range from 5 to 35. |
| Secondary | Change in irritability behavior frequency counts at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | Persons with autism can often display repetitive behaviors. These repetitive behaviors, such as rocking, hitting, kicking, will be counted pre-dose and during intervals post-dose. |
| Secondary | Clinical Global Impressions - Improvement (CGI-I) score at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | The CGI-I is a 7 point scale that will be used to assess global improvement in the patient's condition on a scale that ranges from 0 "not assessed", 1 "very much improved" to 7 "very much worse". |
| Secondary | Clinical Global Impressions - Efficacy (CGI-E) score at 30 minutes post-dose | Pre-dose to 30 minutes post-dose | The CGI-E is a scale that measures the efficacy of an intervention balanced by any negative side effects. Scores can range from 1 (vast improvement and no side effects) to 16 (unchanged or worse and side effects that outweigh therapeutic effect). |
| Secondary | Change in modified Aberrant Behavior Checklist - Irritability Subscale (ABC-I) score at 60 minutes post-dose | Pre-dose and at 60 minutes post-dose | The ABC-I lists15 behaviors, including aggression, tantrums, crying, seen with irritability and these are scored from 0 "absent" to 3 "severe". Score can therefore range from 0 to 45 (worst irritability). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32609960 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05163717
GET https://conductscience.org/api/trials/v1/NCT05163717/registered