Trial · NCT05163717
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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). |
| Secondary | Time to reach an ACES score of 4 (normal) post-dosing | Dosing until 120 minutes post-dose | The length of time it will take the participant to move from a score of 2 or 1 on the ACES scale to a score of 4 will be determined. |
| Secondary | Frequency of administering pharmaceutical rescue intervention within 120 minutes after dosing | Dosing until 120 minutes post-dose | The frequency of administering any pharmaceutical intervention other than the study intervention from dosing until 120 minutes after dosing will be recorded and compared for INP105 versus placebo. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05163717/registered