Clinical Trials

Numerous early- to late-phase clinical trials evaluate the safety and efficacy of rizatriptan benzoate monotherapy and combination formulations, such as AXS-07, for acute, episodic, and vestibular migraine, as well as chronic post-traumatic headache. Sponsored by pharmaceutical entities including Merck Sharp & Dohme and Axsome Therapeutics alongside clinical centers like the Diamond Headache Clinic and IRCCS San Raffaele, most of these investigations are completed. However, several clinical trials actively recruit participants to assess novel formulations, while a small subset has been withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06473597 RECRUITING
Migraine
Antonios Likourezos
 2024-09-01 PHASE4
NCT05550207 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2022-08-31 PHASE3
NCT04384367 COMPLETED
Migraine
Eurofarma Laboratorios S.A.
 2022-12-30 PHASE3
NCT04068051 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2019-07-06 PHASE3
NCT02447991 COMPLETED
Vestibular Migraine; Migrainous Vertigo
Robert W. Baloh
 2014-12 PHASE2; PHASE3
NCT04163185 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2019-10-08 PHASE3
NCT03896009 COMPLETED
Migraine
Axsome Therapeutics, Inc.
 2019-03-04 PHASE3
NCT00719134 COMPLETED
Episodic Migraine
Beth Israel Deaconess Medical Center
 2008-09 PHASE4
NCT01306266 WITHDRAWN
Chronic Post-traumatic Headache
Henry M. Jackson Foundation for the Advancement of Military Medicine
 2011-02
NCT01001234 COMPLETED
Migraine, Acute
Organon and Co
 2009-11-30 PHASE3
NCT01004263 COMPLETED
Acute Migraine With or Without Aura in Adolescents
Organon and Co
 2009-12-01 PHASE3
NCT00753311 COMPLETED
Migraine
IRCCS San Raffaele
 2009-07 PHASE4
NCT00604812 COMPLETED
Migraine Disorders
Organon and Co
 2007-12-17 PHASE1
NCT01057160 COMPLETED
Migraine
Universität Duisburg-Essen
 2008-05 PHASE4
NCT00894556 COMPLETED
Acute Migraine
Organon and Co
 2009-06-10 PHASE3
NCT00812006 COMPLETED
Migraine
Organon and Co
 2009-03-24 PHASE3
NCT00443209 COMPLETED
Migraine
Merck Sharp & Dohme LLC
 2007-02-21 PHASE3
NCT00360282 COMPLETED
Migraine
University of Pittsburgh
 2006-08
NCT00516737 COMPLETED
Migraine
Organon and Co
 2007-10-03 PHASE3
NCT00397254 COMPLETED
Migraine
Clinvest
 2006-12 PHASE4
NCT00300924 COMPLETED
Migraine
Diamond Headache Clinic
 2006-03 PHASE3
NCT00250458 COMPLETED
Migraine
Organon and Co
 2006-03 PHASE3
NCT00246337 COMPLETED
Migraine
Merck Sharp & Dohme LLC
 2005-11 PHASE2
NCT00300924 Completed
Migraine
Diamond Headache Clinic|Merck Sharp & Dohme LLC
 2006-03 Phase 3
NCT00111709 COMPLETED
Migraine
Organon and Co
 2005-05-27 PHASE3
NCT00111722 COMPLETED
Migraine
Organon and Co
 2005-05-27 PHASE3
NCT00095004 COMPLETED
Migraine
Organon and Co
 2004-10-21 PHASE3
NCT00092963 COMPLETED
Migraine
Organon and Co
 2004-08-17 PHASE3
NCT01286207 COMPLETED
Migraine Disorders
Organon and Co
 1995-03 PHASE3
NCT00898677 COMPLETED
Migraine Headache
Organon and Co
 1995-09 PHASE3
NCT00897104 COMPLETED
Migraine Headache
Organon and Co
 1995-08 PHASE3
NCT00897949 COMPLETED
Migraine Headache
Organon and Co
 1995-03 PHASE3
NCT00899379 COMPLETED
Migraine Headache
Organon and Co
 1995-04 PHASE3
NCT00632385 COMPLETED
Migraine
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-10-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rizatriptan benzoate acts as a selective agonist at serotonin 5-HT1B and 5-HT1D receptors, stimulating signaling pathways that induce vasoconstriction of distended intracranial blood vessels and inhibit the release of pro-inflammatory neuropeptides from trigeminal sensory nerves. This targeted attenuation of neurogenic inflammation and cranial vascular dilation prevents central pain signal transmission, effectively relieving headache symptoms and sensory hypersensitivities in patients experiencing acute migraine attacks.

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>).

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Note: Technical data last updated: Sep 1, 2026.