Oxcarbazepine Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials evaluate oxcarbazepine across Phase 2, Phase 4, bioequivalence, and observational protocols sponsored by academic institutions, university hospitals, and pharmaceutical companies such as Novartis, Bayer, and Janssen Korea. These studies investigate conditions including epilepsy, multiple sclerosis, contraceptive drug interactions, and single-dose pharmacokinetics in healthy participants. Recruitment status varies across this landscape, with completed recruitment achieved in Phase 2 neuroprotection and Phase 4 pharmacokinetic evaluations, while observational studies maintain an unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02104661	Completed	Multiple Sclerosis	Queen Mary University of London\|National Multiple Sclerosis Society\|Novartis Pharmaceuticals\|Barts & The London NHS Trust\|University College London\|Royal Free Hospital NHS Foundation Trust\|Mid and South Essex NHS Foundation Trust\|St George''s Healthcare NHS Trust\|Barnet and Chase Farm Hospitals NHS Trust	2014-10	Phase 2
NCT02098941	Unknown status	Epilepsy	Seoul National University Hospital\|Janssen Korea Ltd. Korea	2014-03	--
NCT02362373	Completed	Epilepsy\|Contraception	Columbia University\|Bayer	2011-08	Phase 4
NCT00951847	Completed	Healthy	Ranbaxy Laboratories Limited\|Ranbaxy Inc.	2006-10	Not Applicable
NCT00951600	Completed	Healthy	Ranbaxy Laboratories Limited\|Ranbaxy Inc.	2006-09	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Oxcarbazepine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxcarbazepine functions by binding to and inhibiting voltage-gated sodium channels, thereby blocking sodium ion influx and dampening repetitive, high-frequency action potential generation in hyperactive neurons. This attenuation of neuronal hyperexcitability suppresses pathological seizure activity in epilepsy and provides a rationale for neuroprotective strategies in demyelinating conditions such as multiple sclerosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).