None listed
Conditions
Brief summary
N alpha methyl histamine, possesses a greater affinity for H3 receptors, and could constitute a new therapeutic drug in migraine prophylaxis. OBJETIVE. To compare the superior efficacy of the subcutaneous administration of N alpha-methyl histamine versus oral propranolol in migraine prophylaxis, undertaking double-blind, placebo-controlled study. Hypothesis That subcutaneously injected N alpha methyl histamine (1-3ug) is more effective than propranolol (120mg/ day) in migraine prophylaxis. Null Hypothesis There is no difference between the subcutaneous administration of N- alpha methyl histamine in doses of 1-3 ng and oral propanolol as prophylactic agents against migraine METHODS. A randomized, double–blind study in 60 patients with migraine, male or female adults between the ages of 18 and 65 years. Selected patients will undergo a one-month period of prophylactic agent washout, they will then be divided into two groups for treatment in randomized blocks of three, double-blind fashion: N-alpha metyl histamine study group (n=30) and the propranolol control group (n=30). The treatment will consist of subcutaneous (back region of the upper arm) administration of N alpha methyl histamine twice a week, plus an oral placebo for a period of twelve weeks. Therapy with propranolol will begin at 40 mg/day for one week; until a total daily dose of 120 mg/day for a period of twelve weeks; plus a subcutaneous placebo. The variables we will study are: headache frequency; intensity of pain; duration of pain; intake of rescue analgesics and MIDAS. Statistical Analysis: The intent-to-treat (ITT) population will include all randomized patients. Two-tailed Student’s t test. Mann-Whitney U rank sum test. In order to analyze the temporal course of each treatment, a Friedman repeated measures ANOVA on ranks test will be used to evaluate the statistical significance of differences between basal values and values found for the 4th, 8th, and 12th weeks of treatment. This study has been approved by the Ethical and Scientific Committee of our hospital.
Interventions
a) Name of the treatment: N alpha methyl histamine in Evan’s solution (phenol 0.4%, isotonic sodium chloride) (10 ug/ml)
b) Dose administered 0.1 ml
c) Frequency and duration administered: twice a week for 12 weeks
d) Mode of administration: subcutaneous injection into back region of the upper arm.
The number of treatment/control arms in this trial.
Arm 1: N alpha methyl histamine + placebo propanolol
Arm 2: placebo N alpha methyl histamine + propanolol
Sponsors
Hospital General deZona 1 Intituto Mexicano del Seguro Social
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria.—The study will include outpatient male and female patients of any race between the ages of 18 and 65 years who have been diagnosed with migraine not attributable to another cause; with or without aura occurring for at least 15 consecutive days in a month, for 3 months in the absence of medication overuse. Migraine must have at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, and/or aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs). With the following occurring during the attack: nausea and/or vomiting or photophobia and/or phonophobia.
Exclusion criteria
Exclusion Criteria.—The following criteria are grounds for exclusion: female patients who are pregnant (positive urine pregnancy test) or planning to become pregnant during the study period, are breast feeding, or are of childbearing potential and not practicing a reliable method of birth control; patients with evidence of underlying conditions judged to preclude treatment with either test medication; patients who have previously used study medications for any reason; patients unable to discontinue any prohibited medication(s) including carbonic anhydrase inhibitors (eg, acetazolamide, dichlorphenamide), digoxin, metformin, central nervous system depressants (including alcohol), nonstudy anticonvulsant or antiepileptic medications, agents that might interfere with neuromuscular function (eg, aminoglycoside antibiotics, curare-like agents), or hormonal contraceptives; patients with evidence of recent alcohol/drug abuse or acute medication overuse; patients with diabetes mellitus, liver or kidney disease, recent (within 3 months) sepsis or vascular surgery, history of clinically significant pulmonary disease (eg, chronic obstructive pulmonary disease, asthma) active within the previous 12 months, history of heart attack or stroke, cardiac disorder (eg, any clinically significant dysrhythmia), aortic aneurysm, as well as patients at intermediate or higher risk for cardiac disease defined as having 2 or more major risk factors (cigarette smoking, hypotension).
Outcome results
None listed