Migraine headache with and without aura MedDRA version: 9.1 Level: LLT Classification code 10058734 Term: Migraine prophylaxis
Conditions
Interventions
Product Name: Hydroxocobalamin Acetate (Vitamin B12) Intranasal
Product Code: AST-726
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Hydroxocobalamin
CAS Number: 13422-51-0
Current Sp
Sponsors
Ariston Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A multicenter, randomized, double blind, placebo-controlled, 3 group, parallel group design with moderate to severe migraine patients to assess the ability of daily administration of AST-726 at one of 2 doses to prophylactically reduce the number of migraine days in a 4 week period more than in subjects treated with placebo.;Secondary Objective: Number of subjects that respond with at least a 50% decrease in migraine days in each given 4 week Treatment Period will serve as a secondary endpoint. Additionally, the number of migraine headache attacks will serve as a secondary endpoint. ;Primary end point(s): The primary outcome variable will be change during each treatment period in headache days per month relative to baseline. A “headache day” will be defined as any day in which a patient reports a migraine headache episode of at least 60 minutes. The number of headache days reported in the patient diary will be standardized against a theoretical 30 day period reflecting the Baseline Period (Visit #2 to Visit #3) and the first through third Treatment Periods (Visits #3 to #4, Visits #4 to #5 and Visits #5 to #6, respectively). The standardized number of headache days will be calculated as the number of headache days in a given period divided by the number of days diary data observed multiplied by 30 days. Change in number of headache days during each of the three treatment periods will be calculated by subtracting the number of headache days during the baseline period from the number of headache days in each given treatment period. The primary time point will be the third Treatment Period (data obtained between Visits #5 and #6). | — |
Countries
Finland, United Kingdom
Outcome results
None listed