A Study to Evaluate the Effects of Milnacipran on Pain Processing and Functional MRI in Patients With Fibromyalgia
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/10/2017 |
| Start Date: | June 2010 |
| End Date: | June 2012 |
A Randomized, Double-blind,Placebo-controlled, Two-way Crossover Study to Evaluate the Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging Activation Patterns in Patients With Fibromyalgia
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.
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.
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.
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.
Inclusion Criteria:
- You may be eligible to take part in this study if the following are true:
- You are between the age of 18 and 70 years
- If you are female
- If you are right handed
- You have a diagnosis of fibromyalgia for at least 3 months, as defined by the
American College of Rheumatology 1990 Criteria
- You are willing to stop taking certain medicines that you may be taking on a
regular basis. The researchers will discuss these medications with you in detail
Exclusion Criteria:
- You may not be eligible take part in this study if any of the following are true for
you:
- You have problems with your heart or cardiovascular system
- You have problems with your liver or kidneys
- You have an autoimmune disease, or a whole-body infection like HIV or hepatitis
- You have cancer
- You are pregnant or breastfeeding
- You abuse drugs or alcohol
- You have suicidal thoughts or wishes
- You have taken milnacipran or another study drug within the last 30 days
- You have a medical problem not listed here that would make it unsafe for you to
take part in the study
- The research team feels that you will be unable to complete all phases of the
study
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