Numerous clinical trials spanning early- to late-phase evaluation have investigated ethosuximide across neurological, psychiatric, and pain-related conditions, focusing on childhood absence epilepsy, peripheral neuropathic pain, treatment-resistant depression, and irritable bowel syndrome. Predominantly sponsored by academic medical centers and university hospitals, these studies encompass diverse recruitment statuses, including completed, actively recruiting, terminated, and unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04217733 | RECRUITING | IBS - Irritable Bowel Syndrome |
Tanta University |
2019-11-01 | PHASE3 |
| NCT04431778 | UNKNOWN | Peripheral Neuropathic Pain |
University Hospital, Clermont-Ferrand |
2020-11-01 | PHASE2 |
| NCT02973542 | COMPLETED | Irritable Bowel Syndrome |
University Hospital, Clermont-Ferrand |
2018-02-08 | PHASE2 |
| NCT03887624 | COMPLETED | Depressive Disorder, Treatment-Resistant |
Zhejiang University |
2019-05-21 | EARLY_PHASE1 |
| NCT02973542 | Unknown status | Irritable Bowel Syndrome |
University Hospital Clermont-Ferrand|SFETD (Socièté Française d''Etude et de Traitement de la Douleur) |
2018-04-30 | Phase 2 |
| NCT02100046 | COMPLETED | Neuropathic Traumatic Pain; Pain NRS ≥ 4; Peripheral Neuropathic Pain; Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4 |
University Hospital, Clermont-Ferrand |
2014-03 | PHASE2 |
| NCT01278004 | COMPLETED | Cancer; Peripheral Neuropathy |
Royal Marsden NHS Foundation Trust |
2010-05 | PHASE2 |
| NCT01122381 | TERMINATED | Headache, Migraine |
US Department of Veterans Affairs |
2011-12 | PHASE1; PHASE2 |
| NCT02100046 | Completed | Neuropathic Traumatic Pain|Pain NRS ≥ 4|Peripheral Neuropathic Pain|Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4 |
University Hospital Clermont-Ferrand|Fondation Apicil |
2014-03 | Phase 2 |
| NCT00088452 | COMPLETED | Childhood Absence Epilepsy; Petit Mal Epilepsy; Epilepsy; Seizures |
Children's Hospital Medical Center, Cincinnati |
2004-07 | PHASE3 |
| NCT00689585 | TERMINATED | Complex Regional Pain Syndromes |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2008-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2020-01-03)
Check the
Ethosuximide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.