Rufinamide Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Multiple clinical trials sponsored by commercial entities, including Eisai, have evaluated the therapeutic application of Rufinamide for Lennox-Gastaut syndrome, a severe form of childhood-onset epilepsy. These completed investigations encompass a Phase III long-term extension study investigating prolonged patient outcomes and an observational European registry assessing antiepileptic drug utilization.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01151540	Completed	Lennox-Gastaut Syndrome	Eisai Co. Ltd.\|Eisai Inc.	2010-11	Phase 3
NCT01991041	Completed	Lennox-Gastaut Syndrome	Eisai Limited\|Eisai Inc.	2008-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rufinamide acts as a voltage-gated sodium channel inhibitor by binding to sodium channels and stabilizing their inactive conformation, thereby preventing rapid sodium influx and reducing high-frequency repetitive neuronal action potential generation. By suppressing neuronal hyperexcitability and sustained burst firing, this mechanism dampens abnormal central electrical discharges to control severe seizure frequency in patients with Lennox-Gastaut syndrome.

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>).