Effect of Milnacipran on Pain in Fibromyalgia

Completed · Phase 4

Conditions studied: Fibromyalgia

In brief

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

Key facts

Study ID

NCT01288807

Run by

University of California, San Diego

People needed

8

Starts

2011-02-01

Expected to finish

2015-01-01

Last updated by the study team

2019-09-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD Medical Center, La Jolla — San Diego, California, United States

Full record on ClinicalTrials.gov

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