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NCT03292848
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
Phase 1 trial testing Brexpiprazole in ADHD in 24 participants. Completed in 21 May 2018.
21 May 2018
Quick facts
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 10 October 2017 |
| Primary completion | 21 May 2018 |
| Estimated completion | 21 May 2018 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- Brexpiprazole (BREXPIPRAZOLE) — full drug profile →
Conditions studied
- ADHD — all drugs for ADHD →
- Autism — all drugs for Autism →
- Bipolar I Disorder — all drugs for Bipolar I Disorder →
- Conduct Disorder — all drugs for Conduct Disorder →
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →
Who can join
Adults 6 to 12, any sex, with ADHD or Autism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Immune Abnormalities in Autism Spectrum Disorder-Could They Hold Promise for Causative Treatment?
Gładysz D, Krzywdzińska A, Hozyasz KK. · · 2018 · cited 77× · PMID 29307081 · DOI 10.1007/s12035-017-0822-x
Verify or expand the search:
- PubMed search for NCT03292848
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials
Trials by the same sponsor.
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- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07455084 — A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults · Phase 1 · not yet recruiting
- NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
- NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting
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 NCT03292848 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Last refreshed: 12 June 2018
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/NCT03292848.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing