Dr. Tobias Moeller-Bertram and his associates are conducting a research study sponsored by Forest Laboratories Inc. to evaluate the effectiveness of Savella (milnacipran) in patients suffering from Fibromyalgia. Savella has already been approved by the United States Food and Drug Administration (FDA) for the treatment of Fibromyalgia. Your participation in this study will help us to better understand the ways in which Savella works.
Eligible volunteers:
1. Female participants, 18 years of age or older.
2. Diagnosis of Fibromyalgia.
3. Pain greater than 4 on average over the last week.
4. Pain lasting greater than 6 months.
5. Not pregnant.
6. Ability to speak and understand English to follow instructions and fill out study questionnaires.
7. Must be ambulatory and able to lay prone for 30 minutes.
Not Eligible:
1. Serious, unstable medical illness for which hospitalization is likely over the next 3 months
2. History of schizophrenia, other psychotic disorder, bipolar disorder, organic mental disorder, borderline or antisocial personality disorder, alcohol or substance dependence
3. Known, uncontrolled serious systemic disease including cardiac or respiratory disease, renal or hepatic insufficiency or other serious diseases.
4. Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
5. Known allergy or sensitivity to any of the components in the study medication or to contrast dye.
6. Patients on coumadin or heparin or any other known increased risk of bleeding.
7. Signs for increased intracranial pressure per patient history and exam.
8. Not able to discontinue current pain medication.
9. Allergy or contraindication to acetaminophen.
10. Use of monoamine oxidase inhibitors (MAOIs).
11. Uncontrolled narrow-angle glaucoma.
For more information, please contact:
Meegin Kincaid
Tel. 858-552-8585 x2386
meegin.kincaid@va.gov
Clinical Research Coordinator
Veterans Health Administration, La Jolla
Anesthesiology/Research Service
University of California, San Diego Medical Center
Center for Pain Medicine