Amantadine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate amantadine across diverse indications, including glioblastoma multiforme, general oncology, Parkinson's disease-related dyskinesias, and metabolic biomarker monitoring. These investigations encompass Phase II trials alongside observational or diagnostic protocols, sponsored by academic institutions like the University of Manitoba and CancerCare Manitoba as well as pharmaceutical entities such as Novartis. Recruitment statuses across these studies range from recruiting and completed to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04530006	Recruiting	Glioblastoma Multiforme	CancerCare Manitoba\|University of Manitoba\|The Metabolomics Innovation Centre\|BioMark Diagnostics Inc.\|Canadian Institutes of Health Research (CIHR)	2020-12-02	Not Applicable
NCT02277938	Unknown status	Cancer	University of Manitoba\|BioMark Technologies Inc.\|St. Boniface Hospital	2013-08	--
NCT01491529	Completed	Dyskinesias\|Parkinson Disease\|Movement Disorders\|Parkinsonian Disorders\|Anti-Dyskinesia Agents	Novartis Pharmaceuticals\|Novartis	2012-04	Phase 2
NCT01467258	Completed	Healthy Metabolism	University of Manitoba\|St. Boniface Hospital	2011-11	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amantadine selectively binds to and blocks the ion channel formed by the M2 protein across the viral membrane, which disrupts proton transport, inhibits viral uncoating, and prevents intracellular viral replication. Additionally, through its modulating effects on central neurochemical transmission, this target activity provides therapeutic benefit by relieving tremors and movement disorders evaluated in clinical trials for Parkinson's disease.

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>).