A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine

Inclusion Criteria

• Diagnosis of migraine, with or without aura, according to ICHD-2 criteria (Appendix A) for at least 1 year prior to screening; experience an average of 1 to 8 migraines per month.
• Females must be practicing an effective method of birth control before entry and throughout the study, or be surgically sterile, or be postmenopausal
• Females of child-bearing potential must have a negative urine pregnancy test
• Subjects should be able to demonstrate the ability to properly administer study medication
• Subjects should be able and willing to read and comprehend written instructions and complete the diary information required by the protocol
• Subjects must be capable, in the opinion of the Investigator, of providing informed consent or assent to participate in the study
• Subjects (and their legally acceptable representatives, if applicable) must provide an informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria

• Inability to distinguish other headaches from migraine
• Experiences headache of any kind at a frequency greater than or equal to 15 days per month
• Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
• Chronic opioid therapy for headaches (> 3 consecutive days in the 30 days prior to screening)
• Hemiplegic migraine
• History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes
• History of glaucoma and/or current treatment with prescription eye drops
• History of naso-lacrimal duct ("tear duct problem" to patients) obstruction or surgery for such
• Active treatment by ophthalmologist or optometrist for any severe ophthalmic disease or problem
• Any physical problems or co-ordination difficulty or eye avoidance sensitivity ("squeezer") that would preclude proper installation of eye drops in either or both eyes
• History of uncontrolled asthma, COPD, or reversible airway disease which in the opinion of the investigator would be worsened by the use of beta blockers
• History of clinically symptomatic bradycardia, congestive heart failure, or hypotension
• Uncontrolled Diabetes Mellitus
• Uncontrolled Hyperthyroidism
• History (within 2 years) of drug or alcohol abuse
• Systemic disease, which in the opinion of the Investigator, would contraindicate participation
• History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation
• History of hypersensitivity or intolerance to beta-blockers eye drops
• Pregnant or lactating women
• Have taken any investigational medication within 12 weeks before randomization, or are scheduled to receive an investigational drug
• Subjects, who in opinion of the Investigator, should not be enrolled in the study because of the precautions, warnings or contra-indications sections of the timolol Package Insert