A Randomized Study Evaluating the Efficacy and Safety of Timolol Ophthalmic Solution as an Acute Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Timolol; Placebo
Intervention description: Timolol is a clear solution supplied in a plastic ophthalmic dispenser.; Placebo is normal saline solution that will be supplied in container matched to Timolol container.
Intervention MeSH terms: Timolol; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache; Acute migraine headache

Summary:

      The purpose of this study is to assess the efficacy (headache freedom at 2 hours) of Timolol
      0.5% ophthalmic solution compared to placebo in acute treatment of migraine headache. And to
      assess the safety and tolerability of Timolol 0.5% ophthalmic solution in treatment of acute
      migraine headache.
    

Eligibility criteria:

        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