Do You or Someone You Know Get Headaches at Least 15 Days Each Month?
Volunteers are needed for a clinical trial testing a currently available muscle relaxant medication for an investigational indication of chronic migraine. This trial is no longer accepting new participants.
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, Director of The Headache Center, part of Kennedy Health Alliance in Cherry Hill, NJ, is the principal investigator of this investigator-initiated clinical trial. She is a headache specialist who has treated headache sufferers and conducted headache research for more than 20 years.
3. What are study enrollment dates and numbers to be enrolled?
This clinical trial is about halfway completed and is expected to enroll into 2014 for a target enrollment of 70 chronic migraine patients.
4. What are the qualifications for study enrollment?
The investigator will make the final determination whether you meet study protocol inclusion and exclusion criteria.
Some criteria for participants are as follows:
- Age 18 to 65
- At least 15 days of headaches per month lasting at least 30 minutes (if not treated). Eight of these 15 days must have at least one of the following features OR must be treated with migraine-specific medications (triptans):
- predominantly one-sided head pain, throbbing quality of pain, sensitivity to light, sensitivity to sound, nausea, vomiting, or aggravation of pain with physical 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 two months prior to enrollment, maintained at a stable dose for at least one 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 one 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 three office visits.All visits will be scheduled at convenient hours for you and your time will be respected.
- The study will consist of one phone contact or office visit to distribute a one- 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 one peak 24-hour pain rating (0-5), one average 24-hour pain rating (0-5), a migraine symptom checklist, and will list any acute headache medications used for each day.
- You will briefly discuss your one-month pre-treatment diary on the phone before first visit to ensure you still qualify for study medication.
- At initial visit, 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 three months of headache diaries (same as one-month pre-treatment diary) and study medication.
- At visit two, one 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 three, 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 $50 for each study visit and one phone contact, for a total of $200. If you do not complete the study, you will receive $50 for each completed 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. If you would like to participate, or would like further information, please call Dr. Loretta Mueller at The Headache Center, Kennedy Health Alliance - Cherry Hill, NJ at (856) 406-4091.
This trial is no longer accepting new participants.