A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis

Summary

This is a prospective multi-center, randomized, double-blind, two treatment period, placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive either AGH-201 sc or placebo (matching vehicle only) sc for 16 weeks. The safety and efficacy outcome measures will be assessed at selected dosing segments during the 16 week treatment phase and 4 weeks (week 20), 8 weeks (week 24) after the last Injection.

Timeline

Start

2022-10

Primary completion

2023-07

Completion

2023-07

Publications

• Results Millan-Guerrero RO, Isais-Millan R. [New therapeutic alternatives in migraine prophylaxis using histamine H3 receptor agonists]. Gac Med Mex. 2008 Jul-Aug;144(4):291-5. Spanish.
• Results Millan-Guerrero RO, Isais-Millan S, Barreto-Vizcaino S, Rivera-Castano 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.1468-1331.2008.02352.x.
• Results Millan-Guerrero RO, Isais-Millan R, Barreto-Vizcaino S, Gutierrez I, Rivera-Castano L, Trujillo-Hernandez B, Baltazar LM. Subcutaneous histamine versus topiramate in migraine prophylaxis: a double-blind study. Eur Neurol. 2008;59(5):237-42. doi: 10.1159/000115637. Epub 2008 Feb 8.
• Results Millan-Guerrero RO, Isais-Millan R, Barreto-Vizcaino S, Rivera-Castano L, Garcia-Solorzano A, Lopez-Blanca C, Membrila-Maldonado M, Munoz-Solis R. Subcutaneous histamine versus sodium valproate in migraine prophylaxis: a randomized, controlled, double-blind study. Eur J Neurol. 2007 Oct;14(10):1079-84. doi: 10.1111/j.1468-1331.2007.01744.x.
• Results Millan-Guerrero RO, Isais-Millan R, Benjamin 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. doi: 10.1017/s0317167100004960.
• Results Millan Guerrero R, Trujillo Hernandez B, Tene CE. [Subcutaneous histamine in migraine prophylaxis. Initial effects and long-term outcome]. Neurologia. 2006 Mar;21(2):55-9. Spanish.

Drugs

Indications

No indication recorded.