A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis
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ClinicalTrials.gov Identifier: NCT02021474 |
Recruitment Status :
Not yet recruiting
First Posted : December 27, 2013
Last Update Posted : July 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Migraine Prophylaxis | Drug: AGX-201 Drug: Subcutaneous placebo (Evan's solution = phenol 0.4%, isotonic sodium chloride). | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Phase II Study to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis |
Estimated Study Start Date : | October 2022 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: AGX-201
Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis.
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Drug: AGX-201
Subcutaneous injection |
Placebo Comparator: Evan's solution = phenol 0.4%, isotonic sodium chloride
Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous AGX-201 for Migraine Prophylaxis.
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Drug: Subcutaneous placebo (Evan's solution = phenol 0.4%, isotonic sodium chloride).
Subcutaneous injection
Other Name: Placebo |
- Mean change from baseline in monthly migraine days [time frame: baseline and average over Weeks 3-22]. [ Time Frame: 4 week intervals over weeks 3-22 ]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 by 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22]. [ Time Frame: 4 week time interval ]Mean change from baseline in monthly migraine days by 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22].
- Mean Change from Baseline in Monthly Migraine Index (MMI) [ Time Frame: Baseline and average over observation period (weeks 3-22) ]
Mean Change from Baseline in Monthly Migraine Index (MMI) [ Time Frame: baseline and average over observation period (Weeks 3-22).
Monthly Migraine Index (MMI):
Migraine headaches are assigned a number based on the peak intensity of that migraine headache:
- 1 for a mild migraine headache
- 2 for a moderate migraine headache
- 3 for a severe migraine headache.
The MMI is calculated as follows:
MMI= Sum of [(Migraine Peak Intensity Level (1-3)) x (Migraine Duration (hours))] / (Distinct Number of Migraine Headaches for that 4 week period)
Sample Calculation:
The patient experiences 3 migraine headaches (M1, M2, and M3) in 4 weeks . M1: Intensity Level 3, Duration is 7 hrs M2: Intensity Level 2, Duration 3 hrs M3: Intensity Level 3, Duration 15 hrs MMI= (3x7 + 2x3 + 3x15) / 3 = 24
- Mean change from baseline in monthly number of migraines [ Time Frame: Baseline and over weeks 3-22 ]Mean change from baseline in monthly number of migraines [time frame: baseline and over Weeks 3-22].
- Mean change from baseline in monthly number of migraines [ Time Frame: 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22]. ]Mean change from baseline in monthly number of migraines by 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22].

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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),
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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
- History of transmeridian travel (across >3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across >3 time zones) at any time during the study.
Responsible Party: | AgoneX Biopharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT02021474 |
Other Study ID Numbers: |
AGX-201 |
First Posted: | December 27, 2013 Key Record Dates |
Last Update Posted: | July 20, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
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