A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Fibromyalgia is a condition that includes pain, tenderness, stiff muscle, and fatigue.
      Researchers want to find out if "a drug" called milnacipran can help people with
      fibromyalgia. milnacipran (Savella) is approved by the FDA for the management of
      fibromyalgia. In this study, milnacipran will be given to find out more about how it affects
      pain and thinking in people with fibromyalgia.
    

Detailed description: 
      The objective of this study is to evaluate the effect of milnacipran on pain processing in
      patients with fibromyalgia and to assess the correlation between this effect and neural
      activation patterns during functional Magnetic Resonance Imaging (fMRI).

      NOTE regarding Changes in Outcome Measures

      In this Crossover Study, participants were involved for approximately 16 weeks in this
      sequence: a week of preparing for the initial assessments, baseline measurements (Week 0), 6
      weeks on placebo or study drug followed by measurements for effect of drug or placebo (Week
      6); a week of titration off of drug, if appropriate (or continued placebo, if on placebo),
      two weeks of washout, a new baseline assessment (Week 9), six weeks of study drug (or
      placebo), another set of measurements for effect of drug or placebo (Week 15), and a final
      titration period to maintain masking of assignment to drug or placebo. Of 17 participants who
      completed both sequences, data was analyzed for the 15 whose values for all measurement
      variables were usable.

      When Outcome measure data was originally and accurately posted for baseline and change after
      treatment, the time frames listed were 0 and 15 weeks, because the last assessment was
      gathered at approximately week 15 for each person whose data is in the data set. However,
      given the crossover design, it seems more accurate and understandable, to show the time frame
      for the outcome measure as 6 because the participants were each administered drug or placebo
      for six weeks total. (Of course for the Placebo then Study Drug arm, the placebo data was
      collected at week 6, and for the Study Drug then Placebo arm, the drug data was collected at
      week 6, and similarly for the first group the drug data was collected at week 15 (first
      assignment, plus 1 week titration, 2 weeks washout, new baseline at week 9, and final
      collection at week 15), and for the second group the placebo data was collected at week 15.

      Thus, outcome measures originally listed for 6 and 9 weeks, which were previously shown as
      "Data Not Reported" were effectively already included within the data presented for change
      from baseline shown in Week 15 in this fashion: 9 week data for the second assignment is part
      of the "week 0 data" for the first assignment, to get pre-treatment baseline for each
      treatment shown. Week 6 data is the post-treatment data which was shown as week 15, but is
      now recategorized as 6 week data. There is no, and never was, any data that could represent
      assignment to drug or placebo for 9 or 15 weeks.

      Additionally, several outcome measures based on fMRI values were always listed in the
      protocol as other outcomes (not secondary outcomes), but had been incorrectly posted in the
      earlier listings on ClinicalTrials.gov. They have been accurately reclassified in the 2017
      resubmission.
    

Intervention name(s): milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.; Placebo will be given orally twice daily in tablet form at different times during the course of the study.
Other intervention name(s): Savella; placebo/sugar pill
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science