Clinical Trials
Multiple Phase 1 and non-interventional clinical trials employ topical or single-dose cinnamaldehyde challenge models to investigate neurosensory mechanisms and vascular reactivity across indications including neuropathic pain, migraine, chemotherapy-induced peripheral neuropathy, pruritus, hyperalgesia, and oropharyngeal dysphagia. Conducted by academic institutions such as Universitaire Ziekenhuizen KU Leuven and Aalborg University as well as pharmaceutical sponsors like Eli Lilly and Company, these protocols feature recruitment statuses ranging from recruiting and completed to withdrawn or terminated. Ultimately, these studies serve as human translational benchmarks to evaluate experimental analgesics and neurosensory modulators.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04415892 | RECRUITING | Chemotherapy-induced Peripheral Neuropathy |
Universitaire Ziekenhuizen KU Leuven |
2019-10-01 | |
| NCT05654298 | COMPLETED | Migraine |
Universitaire Ziekenhuizen KU Leuven |
2022-03-15 | |
| NCT04741620 | COMPLETED | Oropharyngeal Dysphagia; Dysphagia; Swallowing Disorder |
Hospital de Mataró |
2019-01-17 | |
| NCT05654298 | Completed | Migraine |
Universitaire Ziekenhuizen KU Leuven |
2022-03-15 | Not Applicable |
| NCT03943407 | WITHDRAWN | Itch |
Aalborg University |
2019-11-01 | |
| NCT04399525 | COMPLETED | Pruritus |
Universitaire Ziekenhuizen KU Leuven |
2019-10-28 | |
| NCT03700892 | TERMINATED | Smoking; Healthy |
University of North Carolina, Chapel Hill |
2018-10-19 | |
| NCT04183283 | COMPLETED | Healthy |
Eli Lilly and Company |
2019-12-12 | PHASE1 |
| NCT04183283 | Completed | Healthy |
Eli Lilly and Company |
2019-12-12 | Phase 1 |
| NCT04415892 | Unknown status | Chemotherapy-induced Peripheral Neuropathy |
Universitaire Ziekenhuizen KU Leuven |
2019-10-01 | Not Applicable |
| NCT04399148 | COMPLETED | Pruritus |
Universitaire Ziekenhuizen KU Leuven |
2019-06-11 | |
| NCT03132142 | UNKNOWN | Pain; Pruritus; Neuropathic Pain; Dermatology/Skin - Other |
Aalborg University |
2017-04 | |
| NCT02653703 | COMPLETED | Inflammation; Pruritus; Hyperalgesia |
Aalborg University |
2014-10 | |
| NCT01667523 | COMPLETED | Healthy |
Maastricht University Medical Center |
2011-02 |
(data from https://clinicaltrials.gov, updated on 2026-05-05)
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>).