Amitriptyline HCl Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate amitriptyline hydrochloride across Phase 1 through Phase 3 and non-phase designs for indications such as depression, migraine prevention, ultraviolet B-induced rosacea redness, and chemotherapy-induced peripheral neuropathy in patients with solid tumors or hematologic malignancies. Sponsored by academic institutions, medical centers, and national networks, these studies encompass completed, actively recruiting, and unknown statuses, highlighting both historic and ongoing clinical interest in this compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06312813	Recruiting	Rosacea	Wright State University	2024-02-27	Phase 2
NCT02519400	Unknown status	Depression	Asan Medical Center	2015-08	Phase 1
NCT02101892	Completed	Migraine\|Preventive Treatment	Rambam Health Care Campus\|Migraine Research Foundation	2014-04	Not Applicable
NCT00516503	Completed	Chronic Myeloproliferative Disorders\|Leukemia\|Lymphoma\|Lymphoproliferative Disorder\|Multiple Myeloma and Plasma Cell Neoplasm\|Myelodysplastic Syndromes\|Myelodysplastic/Myeloproliferative Neoplasms\|Neurotoxicity\|Pain\|Unspecified Adult Solid Tumor Protocol Specific	Alliance for Clinical Trials in Oncology\|National Cancer Institute (NCI)	2008-02	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amitriptyline hydrochloride potent inhibition of the serotonin transporter and norepinephrine transporter with Ki values of 3.45 nM and 13.3 nM blocks presynaptic monoamine reuptake, elevating synaptic concentrations of serotonin and norepinephrine to modulate central and peripheral neurotransmission. This enhancement of synaptic monoaminergic signaling underlies its clinical utility in treating depression, preventing migraine attacks, and mitigating neuropathic pain associated with chemotherapy-induced neurotoxicity.

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>).