University Headache Center

Headache Trial

Do You Or Someone You Know Get Headaches At Least 15 Days Per Month?

Volunteers needed for a clinical trial testing a currently available muscle relaxant medication for an investigational indication of chronic migraine.

Trial includes free study medication and up to $200 compensation for time and travel.

You may remain on your current medications if you qualify.

Call Donna Grasso at 856-566-2706 or Dr Loretta Mueller (Principal Investigator) at 856-566-7010 to see if you qualify or for further information.

FAQ

   

1. What is the purpose of the study?

   The primary objective of the study is to evaluate the effectiveness and safety of a currently marketed muscle relaxant for chronic migraine.  The study medication is considered investigational because it does not have the indication for headache treatment.

2. Who is performing the study

   Dr Loretta Mueller, clinical associate professor at UMDNJ/SOM and Director of the Headache Center, a division of the Neuromusculoskeletal Institute at the medical school campus in Stratford, NJ is the principal investigator of this investigator-initiated clinical trial.  She is a headache specialist who has treated headache sufferers for nearly 18 years, has been an investigator for dozens of migraine trials, and has extensively published in the field of migraines.   Several physicians from UMDNJ/SOM family medicine offices throughout the South Jersey area are working as co-investigators.   

3. What are study enrollment dates and numbers to be enrolled?

   This clinical trial is expected to enroll from August 2010 through at least November 2012.  Target enrollment is 70 chronic migraineurs.

4. What are the qualifications for study enrollment?

   The investigator will make the final determine whether you meet study protocol inclusion and exclusion criteria.  Some criteria are as follows:

   • Age 18 to 65

   • At least 15 days of headaches per month lasting at least 30 minutes (if not treated).  8 of these 15 days must have at least 1 of the following features OR must be treated with migraine-specific medications (triptans): predominantly 1 sided head pain, throbbing quality of pain, sensitivity to light, sensitivity to sound, nausea, vomiting, aggravation of pain with physicial exertion.

   • Women of childbearing age must not be pregnant or nursing, not planning pregnancy for the duration of the trial, and must be using appropriate birth control if applicable.

   • Certain medications are restricted, such as tricyclic antidepressants (SSRI and SNRI antidepressants are allowed), monoamine oxidase inhibitors, cyclobenzaprine, tramadol, ultracet, and ultram.

   • Most medications may be continued but daily medications that may influence headaches must have been started at least 2 months prior to enrollment, maintained at a stable dose for at least 1 month, and are to be continued at a stable dose for the duration of the trial.  Any recently discontinued daily preventive headache medications must have been stopped at least 1 month prior to enrollment.

   • Certain medical conditions are restricted such as: heart attack, congestive heart failure, difficulty with urination, overactive thyroid, liver disease or other conditions which will be screened for by the investigator.

5. What do I have to do if I enroll in the trial?

   The study will consist of a minimum of 3 office visits and 3 phone contacts.  All visits will be scheduled at convenient hours for you and your time will be respected.

   • The study will consist of 1 phone contact or office visit to distribute a 1 month (28 day diary) which you will complete at home before starting study medication and to sign a brief informed consent giving your permission to participate.  You will record 1 peak 24 hr pain rating (0-5), 1 average 24 hr pain rating (0-5), a migraine symptom checklist, and will list any acute headache medications used for each day.

   • You will briefly discuss your 1 month pre-treatment diary on the phone before visit 1 to make sure you still qualify for study medication.

   • At visit 1 you will read and sign another informed consent. The investigator will review your headache diary and complete a medical history and physical examination. If an EKG report is not available within the last year, an EKG will be done at this office visit.  A blood sample (chemistry panel) will be obtained or a lab slip given at this office visit.  Women of childbearing age will give a urine sample for a urine pregnancy test at this visit.You will complete about 15 minutes of questionnaires, then receive 3 months of headache diaries (same as 1 month pre-treatment diary) and study medication.    For your time you will receive a $50 gift card.

   • At visit 2, 1 month after starting study medication, your weight, blood pressure, and pulse will be checked, your diary reviewed, study medication pills will be counted,and any treatment changes or side effects will be noted.

   • There will be phone contact after the second month of study medication to confirm your continued participation, record treatment changes, and review any side effects.

   • At visit 3, 3 months after starting study medication, you will complete about 15 minutes of questionnaires.  The investigator will review your headache diaries and complete a physical examination.  You will receive $150 for your time and travel expenses at completion of the visit.  If you have used study medication but must end the study before the 3 month study is complete, you will receive $75 at your early completion office visit.

6. What if I change my mind about participating?

   You may withdraw your consent to participate without penalty at any time during the study.  You do not give up any legal rights by signing the informed consent documents.