A Phase 2 interventional study of INP105 and Placebo in Agitation in Adolescents and Young Adults With ASD, sponsored by Impel Pharmaceuticals. Terminated at 2 sites in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Impel Pharmaceuticals · Phase 2, Interventional, and Treatment
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Among 603 studies in Autistic Disorder with a site in United States — 123 open to participants now, 152 under way, 3 of them phase 3. Autistic Disorder · United States.
Among the 603 studies in Autistic Disorder with a site in United States, this one is the 463rd largest by enrollment of the 504 interventional ones that give a count, is one of 27 that started in 2022, is one of 95 in phase 2, and was the 432nd registered.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
Browse Autistic Disorder studies →123 of the 603 studies in Autistic Disorder with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 8–12
Vanderbilt University Medical Center · Sites in United States
Ages 36 mo–72 mo
University of Wisconsin, Madison · Sites in United States
Massachusetts General Hospital · Sites in United States
Ages 7–17
Stony Brook University · Sites in United States
Ages 12–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 183 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 143 (78%) stop at 75 or younger; 148 take children under 18; 56 take healthy volunteers.
This study: 12 Years to 21 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
603 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 122 · Phase 3 43 · Phase 4 18
First in 1997; this study’s year is marked. 27 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 8 is below the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Median enrollment 44 across the 504 interventional studies, 135 across the 96 observational. Of the 408 that completed or were terminated, 143 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 603 have an industry lead sponsor. The 10 most frequent:
Impel Pharmaceuticals is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Impel Pharmaceuticals has 1 study filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
34 of the studies in Autistic Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06627205Stanford UniversitySleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism | 2026-12 |
| NCT04805957Rutgers, The State University of New JerseyValidation Digital Bio-markers During Sulforaphane Treatment. | 2026-12-01 |
| NCT07421830Northeastern UniversityAn Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism | 2026-12-31 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
Add all 34 to your calendar (.ics) → With an account.
Among the 603 studies in Autistic Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This 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 and young adults with autism spectrum disorder (ASD) experiencing agitation. Approximately 32 ASD patients who are currently being treated for agitation/aggression at several inpatient units specializing in behavioral treatment will be enrolled.
INP105 is a novel combination product that sprays a powder formulation of olanzapine to the upper nasal space. An earlier formulation showed a similar extent, but faster rate of absorption compared to the approved intramuscular product. In this study, 5 mg of olanzapine or placebo will be delivered nasally by this combination product to moderately or severely agitated participants.
Participants will undergo several screening assessments, including observation session(s) of episode(s) of agitation resulting from a frustration task (eg, a non-preferred activity). At least one observation session must result in a documented moderate to severe agitation episode prior to the participant being eligible to enroll in the study and be randomized to treatment.
The study will be conducted in 2 phases. A pilot phase will initially enroll at least 6 participants, who will receive both 5 mg INP105 (5 mg olanzapine) and placebo in random order, in the same crossover design as later participants. Participants will be dosed during a documented moderate to severe episode of agitation. Once 6 participants have completed both dosing periods and have at least 48 hours of post-dose safety data collected, a safety and preliminary efficacy analysis will be performed by an independent unblinded statistical group, and a summary report forwarded to a sponsor-led Data and Safety Review Committee (DSRC), who will remain blinded. Enrollment will be paused during the DSRC pilot phase safety and preliminary efficacy results review. Absent any concerning safety signals, the second phase will enroll all remaining participants. The DSRC may suggest revisions to the protocol, and the protocol amended and approved as necessary, prior to further participants being enrolled.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
This study's enrollment of 8 is below the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Impel Pharmaceuticals is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychomotor Agitation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
POD-olanzapine (INP105), 5 mg, single dose, to be delivered to each participant
Combination Product: INP105
POD-placebo, single dose, to be delivered to each participant
Combination Product: Placebo
A single 5 mg dose of POD-OLZ (Precision Olfactory Delivery \[POD®\]-olanzapine)
Also known as: POD-OLZ
A single dose of POD-placebo (Precision Olfactory Delivery \[POD®\]-placebo)
Also known as: POD-placebo, POD-PBO
Incidence of adverse events and serious adverse events in the INP105 and placebo groups up to 48 hours post-dose
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.
Time frame: From dosing to 48 hours post dosing
Overall incidence of adverse events and serious adverse events in the INP105 and placebo groups
All adverse events will be recorded as treatment emergent from after dosing until the next treatment, or until last study visit, as applicable.
Time frame: From dosing to end of follow-up (7 days), or to the start of next blinded treatment (48 hours), as applicable
Change in Agitation-Calmness Evaluation Scale (ACES) score at 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".
Time frame: Pre-dose to 30 minutes post-dose
Change in Behavioral Activity Rating Scale (BARS) score at 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.
Time frame: Pre-dose to 30 minutes post-dose
Change in Overt Aggression Scale (OAS) score at 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.
Time frame: Pre-dose to 30 minutes post-dose
Change in Positive and Negative Syndrome Scale - Excited Component (PEC) score at 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.
Time frame: Pre-dose to 30 minutes post-dose
Change in irritability behavior frequency counts at 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.
Time frame: Pre-dose to 30 minutes post-dose
Clinical Global Impressions - Improvement (CGI-I) score at 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".
Time frame: Pre-dose to 30 minutes post-dose
Clinical Global Impressions - Efficacy (CGI-E) score at 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).
Time frame: Pre-dose to 30 minutes post-dose
Change in modified Aberrant Behavior Checklist - Irritability Subscale (ABC-I) score 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).
Time frame: Pre-dose and at 60 minutes post-dose
Time to reach an ACES score of 4 (normal) post-dosing
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.
Time frame: Dosing until 120 minutes post-dose
Frequency of administering pharmaceutical rescue intervention within 120 minutes after dosing
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.
Time frame: Dosing until 120 minutes post-dose
Ran from Jun 2022 to primary completion in Mar 2023, 9 months.
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This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Impel Pharmaceuticals