Current Studies

MIGRAINE HEADACHES CAN BE SUCH A PAIN!

Northwest NeuroSpecialists is conducting a clinical research study of an investigational inhaled medication for the treatment of migraine headaches.

• you have had migraine headaches for at least one year
• have at least 2 migraine headaches per month
• have an average of 20 or more headache-free days per month
• are 18 to 65 years of age
• are not pregnant, breast-feeding or planning to become pregnant
• do not have a history of severe asthma requiring
  • ICU hospitalization or
  • oral steroids currently or more than 30 days in the last year
  Subjects with mild to moderate asthma will be allowed to participate in the study.

The first 4 to 8 weeks of study participation are the screening or qualification period. The first diagnostic tests, including labs, chest x-rays, EKG's, echocardiograms, and pulmonary function tests, are performed during this period. Throughout the Subject's study participation, they will enter information about their migraines and treatments in an electronic diary similar to a PDA.

Subjects who qualify based on their diagnostic tests results and diary entries will enter the first treatment phase of the study, which may last up to 8 weeks. Subjects will treat one migraine headache with either the investigational inhaled medication or an inhaled placebo. Neither the subject nor the site research team will know whether the Subject is assigned to receive placebo or investigational medication. Subjects are assigned randomly (like a toss of a coin) with a 50/50 chance of receiving either placebo or active medication.

Subjects who complete treatment of a migraine and who continue to qualify based on their diary entries will then enter the open label phase of treatment. Open label means that the Subjects will all be receiving active study medication to treat their migraines and will continue to enter information about their migraines and treatment in the electronic diary. Subjects will be scheduled for office visits every 8 weeks during the first open label treatment period (28 weeks) and every 12 weeks during the second open label treatment period (24 weeks). These visits and planned phone calls or e-mails every 2 weeks are to check on the Subjects' well-being and to perform repeated diagnostic tests to check on their health.

Subjects may also have unscheduled visits during these treatment periods to resupply them with study medication as needed. The length of any one Subject's participation may be from 4 to 66 weeks and will be determined by their headache frequency, compliance with study procedures, and health. All subjects who have received study medication will participate in a two-week follow up period after they have discontinued receiving treatment.

All study-related medications, medical visits, and diagnostic tests will be provided to qualified participants at no financial cost. You may even receive some compensation for time and travel.

For more information on this Migraine study or to find out if you may qualify to participate, please call our study coordinator, Brian Peterson, at 742-1833 today.

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