Multiple clinical trials evaluate flunarizine across various neurological conditions, predominantly focusing on migraine prophylaxis—including migraine without aura, vestibular, adolescent, and chronic subtypes—as well as fibromyalgia, chronic pain, and absence or myoclonic epilepsy. Spanning Phase 1, Phase 2, Phase 4, and non-phase interventional protocols, these studies are sponsored by academic medical centers, university hospitals, and commercial entities such as Aspartes Pharmaceuticals. Recruitment statuses across these investigations vary widely, encompassing completed, actively recruiting, not yet recruiting, terminated, and unknown protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07751497 | NOT_YET_RECRUITING | Vestibular Migraine |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-12-01 | PHASE2 |
| NCT07655700 | NOT_YET_RECRUITING | Migraine Prophylaxis |
Chittagong Medical College |
2026-07-01 | PHASE4 |
| NCT07068815 | NOT_YET_RECRUITING | Migraine Without Aura |
Guangzhou University of Chinese Medicine |
2025-09-01 | PHASE1 |
| NCT06499116 | NOT_YET_RECRUITING | Migraine |
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
2024-10 | PHASE4 |
| NCT07445464 | NOT_YET_RECRUITING | Pharmacokinetic Analysis |
Aspartes Pharmaceuticals, Inc. |
2026-04-09 | PHASE1 |
| NCT07354126 | RECRUITING | Migraine |
Muhammad Aamir Latif |
2025-09-01 | |
| NCT04702971 | UNKNOWN | Migraine |
Taipei Veterans General Hospital, Taiwan |
2021-02-26 | PHASE4 |
| NCT06162819 | UNKNOWN | Migraine; Prophylaxis |
Shalamar Institute of Health Sciences |
2024-01-01 | |
| NCT06153186 | TERMINATED | Childhood Absence Epilepsy; Juvenile Absence Epilepsy; Juvenile Myoclonic Epilepsy |
University of British Columbia |
2019-09-20 | PHASE2 |
| NCT04766762 | UNKNOWN | Migraine Without Aura |
The Third Affiliated hospital of Zhejiang Chinese Medical University |
2021-04-21 | |
| NCT04064814 | COMPLETED | Adolescent Migraine |
All India Institute of Medical Sciences, Bhubaneswar |
2019-09-14 | PHASE4 |
| NCT02747940 | COMPLETED | Chronic Pain; Chronic Migraine; Fibromyalgia |
Taipei Veterans General Hospital, Taiwan |
2015-12 | PHASE4 |
| NCT03712917 | COMPLETED | Migraine |
Ataturk University |
2019-03-01 | |
| NCT02580968 | COMPLETED | Migraine |
Shanghai University of Traditional Chinese Medicine |
2015-03 | |
| NCT02639598 | COMPLETED | Chronic Migraine |
Taipei Veterans General Hospital, Taiwan |
2012-06 | PHASE4 |
| NCT00740259 | COMPLETED | Schizophrenia |
Ambulatório de Bipolaridade |
2004-09 | PHASE4 |
| NCT00752466 | COMPLETED | Human Volunteers; Migraine |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-03 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-07)
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>).