Clinical Trials
Multiple clinical trials spanning Phase 1 to Phase 3 have evaluated dantrolene sodium across conditions including multiple sclerosis, cerebral vasospasm secondary to subarachnoid hemorrhage, statin-induced myopathy, Wolfram syndrome, lumbar spine injury, and hyperthermia. Sponsored by government agencies like the National Institute of Allergy and Infectious Diseases, academic institutions such as Washington University School of Medicine and Tanta University, and commercial entities like Eagle Pharmaceuticals, Inc., these studies encompass various recruitment statuses, ranging from completed to actively recruiting, terminated, or not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06966843 | NOT_YET_RECRUITING | Statins Induced Myopathy |
Tanta University |
2027-10 | PHASE2; PHASE3 |
| NCT03109288 | RECRUITING | Multiple Sclerosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2017-08-11 | PHASE1; PHASE2 |
| NCT04134845 | COMPLETED | Ventricular Tachycardia |
Vanderbilt University Medical Center |
2020-08-21 | PHASE2; PHASE3 |
| NCT03762109 | COMPLETED | Lumbar Spine Injury |
Beth Israel Deaconess Medical Center |
2019-07-29 | PHASE2 |
| NCT02829268 | COMPLETED | Wolfram Syndrome; Diabetes Mellitus; Optic Nerve Atrophy; Ataxia |
Washington University School of Medicine |
2017-01 | PHASE1; PHASE2 |
| NCT01950520 | COMPLETED | Healthy Volunteers |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2014-02-07 | PHASE2 |
| NCT03189433 | TERMINATED | Drug Toxicity Psychotropic Agents Psychostimulants |
Eagle Pharmaceuticals, Inc. |
2017-08-12 | PHASE2 |
| NCT02513095 | COMPLETED | Heat Stroke |
Eagle Pharmaceuticals, Inc. |
2015-09 | PHASE2 |
| NCT01024972 | COMPLETED | Subarachnoid Hemorrhage; Cerebral Vasospasm |
University of Massachusetts, Worcester |
2009-10 | PHASE1; PHASE2 |
| NCT00796900 | TERMINATED | Hyperthermia |
Medical University of Vienna |
2008-05 | PHASE2; PHASE3 |
| NCT00964548 | COMPLETED | Cerebral Vasospasm After Subarachnoid Hemorrhage |
University of Massachusetts, Worcester |
2007-07 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-05-13)
Compliance for Clinical Use
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>).