Clinical Trials

A completed clinical trial evaluated the therapeutic application of transdermal magnesium chloride in patients with fibromyalgia and fibromyalgia syndrome. Designated as a pilot study with a phase classification of Not Applicable, the trial assessed how the intervention influences quality of life parameters in affected individuals. The study received joint support from academic and corporate sponsors, namely the Mayo Clinic and Magnesium Direct.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01968772 Completed
Fibromyalgia|Fibromyalgia Syndrome
Mayo Clinic|Magnesium Direct
 2013-10 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Magnesium chloride acts as an essential ionic electrolyte source that modulates enzymatic cofactors and coagulation cascades, thereby shortening activated partial thromboplastin times and regulating cellular neuromuscular excitability. This biochemical modulation normalizes transmembrane ion gradients and aberrant neuro-signaling pathways, providing therapeutic relevance for alleviating chronic pain symptoms evaluated in clinical trials for fibromyalgia 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>).

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Note: Technical data last updated: Sep 1, 2026.