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NCT04382885
Cariprazine Pediatric ASD PK Study
Phase 1 trial testing Cariprazine in Autism Spectrum Disorder in 24 participants. Completed in 10 December 2021.
10 December 2021
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 26 June 2020 |
| Primary completion | 10 December 2021 |
| Estimated completion | 10 December 2021 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Cariprazine (CARIPRAZINE) — full drug profile →
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
AbbVie — full company profile →
Who can join
Adults 5 to 17, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will be a multi-center, open-label, parallel-group, multiple-dose study in up to 24 male and female participants aged 5 through 17 years, inclusive, with Autism Spectrum Disorder (ASD). The 24 participants will be enrolled into 1 of 4 cohorts (6 participants per cohort).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04382885
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cariprazine
Trials testing the same drug.
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- NCT06433635 — Sequential Multiple Assignment Randomized Trial for Bipolar Depression · Phase 4 · active not recruiting
- NCT05913947 — Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9) · Phase 4 · recruiting
- NCT05368558 — Study to Assess Adverse Events and Change in Disease Activity of Oral Cariprazine Capsules in Adult Participants With Sc · Phase 3 · terminated
- NCT05384483 — Cariprazine Versus Placebo for Social Anxiety Disorder · Phase 4 · completed
Other recruiting trials for Autism Spectrum Disorder
Currently open trials in the same condition.
- NCT07324057 — The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavi · NA · recruiting
- NCT07493096 — Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disor · recruiting
- NCT07505290 — Efficacy of the Korean PEERS® for Preschoolers (PEERS®-PS-K) Social Skills Intervention: A Randomized Controlled Trial f · NA · active not recruiting
- NCT07524192 — A Self-Instructional Online Program for Early Childhood and Elementary Teachers Supporting Autistic Children and Childre · NA · recruiting
- NCT07432776 — Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design · EARLY_PHASE1 · recruiting
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04382885 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AbbVie
- Last refreshed: 12 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04382885.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing