Efficacy of N-Alpha Methyl Histamine versus Propranolol in prevention of miigraine.

Phase 3

• Conditions: migraine prophylaxis; Neurological - Other neurological disorders

• Registration Number: ACTRN12610000126011
• Lead Sponsor: Hospital General deZona 1 Intituto Mexicano del Seguro Social

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified