Effect of Milnacipran on Pain in Fibromyalgia

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators want to study the effects of milnacipran treatment on neurotransmitter release in fibromyalgia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Forest Laboratories; US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Milnacipran

Criteria

Inclusion Criteria:

• Female age 18 or older

• Written informed consent and written release of health and research study information

• Diagnosis of Fibromyalgia

• Participant has pain greater than 4 on the NRS of 0 to 10 on average over the last week prior to initial evaluation that interferes with function most days per week

• Pain duration greater than 6 months

• Negative urine pregnancy test on experimental day 1 and 2 and on first day of treatment prior to administration of study medication and fluoroscopy

• Ability to speak and understand English, to follow instructions, and fill out study questionnaires

• Likely to complete all required visits

• Must be ambulatory and able to lay prone for 30 minutes

Exclusion Criteria:

• Any condition or situation that in the investigator's opinion may put the participant at significant risk, confound the study results, or interfere significantly with the participant's participation in the study

• Serious, unstable medical illness that could lead to hospitalization over the next three months; and/or a DSM-IV diagnosis(es) with active problems within the last six months, such as: schizophrenia, bipolar disorder, antisocial personality disorder, or substance use disorder

• Known, uncontrolled, serious systemic disease, including: hypertension and/or tachyarrythmia

• Females who are pregnant, breast feeding, or who plan to become pregnant, or who may potentially become pregnant

• Allergy or sensitivity to any component of the study medication or to contrast dye

• Patients on coumadin, heparin, or any other known increase risk of bleeding

• Signs of increased intracranial pressure

• Patients who are unable to continue current pain medication

• Allergy or contraindication to acetaminophen

• Use of monoamine oxidase inhibitors

• Uncontrolled narrow-angle glaucoma