NCT02021474 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Millán Guerrero R, Trujillo Hernández B, Tene CE
[Subcutaneous histamine in migraine prophylaxis. Initial effects and long-term outcome]. Neurologia. 2006 Mar;21(2):55-9. Spanish.
Millán-Guerrero RO, Isais-Millán R, Barreto-Vizcaíno S, Gutiérrez I, Rivera-Castaño L, Trujillo-Hernández B, Baltazar LM
Subcutaneous histamine versus topiramate in migraine prophylaxis: a double-blind study. Eur Neurol. 2008;59(5):237-42. doi: 10.1159/0
Millán-Guerrero RO, Isais-Millán R, Barreto-Vizcaíno S, Rivera-Castaño L, Garcia-Solorzano A, López-Blanca C, Membrila-Maldonado M, Muñoz-Solis R
Subcutaneous histamine versus sodium valproate in migraine prophylaxis: a randomized, controlled, double-bli
Millán-Guerrero RO, Isais-Millán R, Benjamín TH, Tene CE
Nalpha-methyl histamine safety and efficacy in migraine prophylaxis: phase III study. Can J Neurol Sci. 2006 May;33(2):195-9.
Millán-Guerrero RO, Isais-Millán R
[New therapeutic alternatives in migraine prophylaxis using histamine H3 receptor agonists]. Gac Med Mex. 2008 Jul-Aug;144(4):291-5. Spanish.
Millán-Guerrero RO, Isais-Millán S, Barreto-Vizcaíno S, Rivera-Castaño L, Rios-Madariaga C
Subcutaneous histamine versus botulinum toxin type A in migraine prophylaxis: a randomized, double-blind study. Eur J Neurol. 2009 Jan;16(1):88-94. doi: 10.1111/j.

Phase II Study to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis

Clinical trial NCT02021474 - References