Intranasal Hydroxocobalamin (AST-726) Treatment for Prohylaxis of Migraine: a Placebo-Controlled, Clinical Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

Inclusion Criteria

1.Male or female between 18 and 75 years of age.
2.No medical conditions that would prohibit compliance with study procedures or conditions based on prestudy medical history, physical examination and routine laboratory tests as determined by the investigator. Subjects must have normally function kidneys as determined by the laboratory tests. (Excessive cobalamins are excreted primarily in the urine.)
3.Has migraine headaches with or without aura according to IHS guidelines (Committee, 2004).
4.Has had migraines for at least 6 months prior to study enrollment period.
5.Migraines began before age 50.
6.Has 2-10 attacks per month and greater than or equal to 3 migraine days per month in the last 3 mo prior to study enrollment. (The subject must be able to indicate they have been under a physicians care or referral for migraines for at least 3 months.
7.Has 2-10 attacks in 30 days during the Baseline Period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Used other intranasal medications within 4 weeks prior to study enrollment.
2.Is pregnant or breast-feeding (nursing) mother. All females of childbearing potential must have a negative blood pregnancy test at screening. Over the course of the study, females must practice a method of contraception with greater then 90% reliability, be sterile or postmenopausal.
3.Has known allergies to vitamin B12 or intranasal sprays.
4.Has headache equal to or greater than 18 days per month.
5.Has used migraine medications (e.g., topiramate, beta-blockers) for prophylactic use within 60 days prior to study enrollment.
6.Has excessive use of acute migraine medications (e.g., triptans, dihydroergotamine (DHE)) greater than 15 days per month.
7.Has taken nitroglycerine-containing medications within 60 days prior to study enrollment.
8.Failed more than 3 clinical studies of effective migraine prevention medications due to uncontrolled migraines.
9.Has had allergic or anaphylactic reaction to food colorants. (Patient may be admitted if they know that their food allergy is not due to a color agent.)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials