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Atypical Antipsychotic

Cariprazine for Autism Spectrum Disorder

Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment 8 weeks
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will assess if cariprazine is safe and effective in treating pediatric participants (5 to 17 years of age) with ASD.

Who is the study for?
This trial is for children aged 5-17 with Autism Spectrum Disorder (ASD) who show significant irritability. They must have specific scores on clinical assessments that measure severity of irritability and confirm an ASD diagnosis. Participants will be randomly assigned to receive either the drug Cariprazine or a placebo.Check my eligibility
What is being tested?
The study tests Cariprazine's safety and effectiveness in reducing irritability due to ASD compared to a placebo, over an 8-week treatment period followed by a 12-week safety follow-up. This double-blind trial means neither participants nor doctors know who receives the actual drug or placebo.See study design
What are the potential side effects?
Potential side effects may include changes in mood or behavior, gastrointestinal issues, sleep disturbances, and other reactions typical of psychiatric medications. Specific side effects related to Cariprazine will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ 8 weeks
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, 8 weeks for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score
Secondary outcome measures
Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score
Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score
Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668
17%
Akathisia
11%
Headache
10%
Nausea
10%
Extrapyramidal disorder
10%
Insomnia
9%
Vomiting
9%
Restlessness
5%
Constipation
5%
Dizziness
4%
Dyspepsia
2%
Mania
2%
Diarrhoea
2%
Tremor
1%
Aggression
1%
Endometrial cancer
1%
Bipolar disorder
1%
Hospitalisation
1%
Pulmonary embolism
1%
Bipolar I disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Cariprazine (3-6 mg/Day)
Cariprazine (6-12 mg/Day)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CariprazineExperimental Treatment1 Intervention
Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo once daily for 8-weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11050

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,243 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
304 Patients Enrolled for Autism Spectrum Disorder
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,957 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
280 Patients Enrolled for Autism Spectrum Disorder

Media Library

Cariprazine (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05439616 — Phase 3
Autism Spectrum Disorder Research Study Groups: Cariprazine, Placebo
Autism Spectrum Disorder Clinical Trial 2023: Cariprazine Highlights & Side Effects. Trial Name: NCT05439616 — Phase 3
Cariprazine (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05439616 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research subjects are part of this investigation?

"Yes, this is an ongoing recruitment according to the latest information from clinicaltrials.gov. The study was first posted on July 7th, 2020 and updated November 9th, 2020. They are looking for 152 individuals total from 28 different sites."

Answered by AI

Which type of patient does this trial cater to?

"This research is looking for children and adolescents that have been diagnosed with autism spectrum disorder. In total, the study will aim to include 152 patients that are between 5-17 years old."

Answered by AI

Is Cariprazine known to have any adverse side effects?

"Cariprazine has received a safety score of 3. This is because Cariprazine is in Phase 3 trials, suggesting that not only does this medication show efficacy, but there are also multiple rounds of data supporting its safety."

Answered by AI

Are older people being included in this experiment?

"This trial is open to young patients that fall between 5 and 17 years of age."

Answered by AI

Are people with the relevant condition able to participate in this research project?

"That is accurate. The clinicaltrials.gov website contains information revealing that this particular study is still recruiting participants. This trial was originally posted on July 7th, 2022 and was most recently edited on November 9th, 2022. Additionally, the study is looking for 152 willing participants at 28 different sites."

Answered by AI

Are there a number of hospitals administering this clinical trial within the state?

"This clinical trial has 28 enrolling patients from locations including K2 Medical Research /ID# 248694 in Maitland, Multicare Institute for Research and Innovation /ID# 245153 in Tacoma, Nona Pediatric Center /ID# 245078 in Orlando, as well as other centres."

Answered by AI

Who else is applying?

What state do they live in?
New York
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Pacific Clinical Research Management Group /ID# 243019
Dr. Hosneara, M.D. LLC /ID# 252129
Recent research and studies
clinicaltrials.govStudy
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
2022. "Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05439616.
All > Autism San Diego > Vraylar
~34 spots leftby Oct 2024
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