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

NCT02021474 | Unknown Phase 2 FDA Drug

• 1 other identifier: AGX-201
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Migraine Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in monthly migraine days [time frame: baseline and average over Weeks 3-22].

  Mean change from baseline in monthly migraine days \[time frame: baseline and average over Weeks 3-22\].

  4 week intervals over weeks 3-22

Secondary Outcomes (4)

• Mean change from baseline in monthly migraine days by 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22].

  4 week time interval

• Mean Change from Baseline in Monthly Migraine Index (MMI)

  Baseline and average over observation period (weeks 3-22)

• Mean change from baseline in monthly number of migraines

  Baseline and over weeks 3-22

• Mean change from baseline in monthly number of migraines

  4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22].

Study Arms (2)

AGX-201

EXPERIMENTAL

Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis.

Drug: AGX-201

Evan's solution = phenol 0.4%, isotonic sodium chloride

PLACEBO COMPARATOR

Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis.

Drug: Subcutaneous placebo (Evan's solution = phenol 0.4%, isotonic sodium chloride).

Interventions

AGX-201 DRUG

Subcutaneous injection

AGX-201

Subcutaneous placebo (Evan's solution = phenol 0.4%, isotonic sodium chloride). DRUG

Subcutaneous injection

Also known as: Placebo

Evan's solution = phenol 0.4%, isotonic sodium chloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any race, 18 to 65 years of age inclusive.
• Patients with a history of migraine (with or without aura) according to the Headache Classification Committee of the IHS. Migraine attacks have to have had an onset before age 50 and have to have been present for at least 12 months.
• Patients with 4-20 qualified migraine attacks per month over the past three months prior to Screening, as well as during the four weeks of the Baseline Phase will be eligible for entry into this study. The interval between two qualified migraine attacks should be at least 24 hours to be counted as distinct migraine attacks. A qualified migraine attack without aura is defined as a headache that lasts 4-72 hours (if untreated or unsuccessfully treated) or if successfully treated. This attack has at least two of the following characteristics: unilateral location, pulsating quality, moderate or severe intensity that inhibits or prohibits daily activities or aggravation by routine physical activities such as walking up stairs. In addition, at least one of the following symptoms must be present during the headache: nausea, vomiting, or photophobia and phonophobia. A qualified migraine attack with aura must fulfill the same criteria as the headache attack, plus have an associated aura as defined by the Migraine Criteria of the Headache Classification Committee of the International Headache Society. An aura alone that requires acute migraine treatment will also be considered a migraine attack.
• Male and female patients will be eligible for enrollment. Females should be either of non-childbearing potential by reason of surgery, radiation, menopause (one year post onset), or of childbearing potential and practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or IUD) for at least one month before study randomization and for two months after the end of the study, and have a negative serum B-hCG at Screening. Pregnant and/or lactating females are excluded. Those women using hormonal contraceptives must also be using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Baseline Phase and continuing throughout the entire study period.
• Patients who are willing to participate and have provided written informed consent prior to being exposed to any study-related procedures.

You may not qualify if:

• Patients with chronic daily headaches as defined by more than 20 headache days per month on average during the three months prior to Screening,
• Patients with cluster headaches and other trigeminal autonomic cephalalgias, and other primary headaches (except tension-type headache) and secondary headaches (defined according to the Headache Classification Committee of the IHS 2004),
• Patients with a history of being non-responsive to more than two classes of adequately conducted, prophylactic migraine treatments (e.g., beta blockers, calcium channel blockers, tricyclics, MAOIs, valproate (divalproex), topiramate, gabapentin),
• Patients who use the following medications as described:
• Use of marketed triptans for 12 days or greater per month on average,
• Use of ergot-containing medications for 12 days or greater per month on average,
• Use of NSAIDs, acetaminophen, or isometheptene-containing agents for 15 days or greater per month on average,
• Use of opioids for 12 days or greater per month on average,  - Use of any two or more of the above medications for 15 days or greater per month on average,
• Patients with clinically significant neurological illness, other than migraine, that, in the opinion of the Investigators, may have the potential of altering pain perception or reporting,
• Patients with a history of or currently having major psychiatric disorders including schizophrenia, major depressive disorder, or bipolar disorder,
• Patients with elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \>= 1.5 times the upper limit of normal (ULN),
• Patients with evidence of significant active hematological disease; White blood cell (WBC) count cannot be \<= 2500/μL or an absolute neutrophil count \<= 1000/μL.
• Patients with clinically significant ECG abnormality, including prolonged QTc (Fridericia correction) defined as \>= 450 msec for males and \>= 470 msec for females,
• Patients with clinically significant active hepatic disease, cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, and bacterial or viral infections within 30 days prior to Screening or during the Baseline Phase,
• Pregnant or lactating females

Sponsors & Collaborators

• AgoneX Biopharmaceuticals, Inc.: lead

Related Publications (6)

• 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.

  PMID: 18942262 RESULT

• 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.

  PMID: 19087155 RESULT

• 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.

  PMID: 18264012 RESULT

• 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.

  PMID: 17880560 RESULT

• 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.

  PMID: 16736729 RESULT

• 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.

  PMID: 16525910 RESULT

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07