Dichlorphenamide Clinical Trials

Size	Price	Qty
10mg	USD 320

Clinical Trials

Multiple completed Phase 3 clinical trials have evaluated dichlorphenamide for the treatment of neuromuscular and ion channel disorders, specifically hyperkalemic periodic paralysis, hypokalemic periodic paralysis, and paramyotonia congenita. Sponsored by academic and non-commercial institutions, including the National Center for Research Resources and the University of Rochester, these investigations define the clinical research landscape for dichlorphenamide in managing periodic paralyses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00494507	COMPLETED	Hyperkalemic Periodic Paralysis; Hypokalemic Periodic Paralysis	University of Rochester	2007-06	PHASE3
NCT00004802	COMPLETED	Paralysis, Hyperkalemic Periodic; Hypokalemic Periodic Paralysis; Paramyotonia Congenita	National Center for Research Resources (NCRR)	1992-06	PHASE3

(data from https://clinicaltrials.gov, updated on 2017-06-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dichlorphenamide binds to and inhibits carbonic anhydrase enzymes, thereby reducing bicarbonate secretion and modulating intracellular pH and transmembrane ion gradients. This inhibition restores potassium balance and stabilizes skeletal muscle membrane potential, alleviating muscle weakness associated with hyperkalemic and hypokalemic periodic paralysis.

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>).