Piracetam Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate Piracetam across distinct applications, including memory disorders and subtherapeutic dosing as a drug adherence marker. Ranging from Phase 4 research to studies designated as Not Applicable, these trials encompass a completed efficacy and safety study sponsored by UCB Pharma as well as a not-yet-recruiting study led by The Netherlands Cancer Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05918341	Not yet recruiting	Drug Adherence Marker	The Netherlands Cancer Institute	2023-07-03	Phase 4
NCT00567060	Completed	Memory Disorders	UCB Pharma	2000-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Piracetam functions as a cyclic derivative of gamma-aminobutyric acid that interacts with cell membrane phospholipids to restore membrane fluidity, thereby potentiating neurotransmitter receptor activity and enhancing neuronal metabolism. This enhancement of synaptic plasticity and central neurotransmission provides the rationale for its clinical utility in treating memory disorders and its evaluation as a drug adherence marker in clinical trials.

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>).